AzTrials
AzTrials

Fallopian Tube Clear Cell AdenocarcinomaPhase 3NCT00719303

Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 3 study testing Behavioral Dietary Intervention, Compliance Monitoring and Counseling in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by Gynecologic Oncology Group at 687 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Behavioral Dietary Intervention, Compliance Monitoring and Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,070 participants
Where
687 sitesUnited States
Study dates
18 Jun 2012to 31 Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner?s tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary M?llerian epithelial adenocarcinoma
  • Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy (chemo) or biological therapy
  • Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institution?s upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen
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  • Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
  • Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization) (previous 12 months), or a history of an eating disorder (anorexia nervosa or bulimia nervosa)
  • Patients must complete all pre-entry assessments
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC

Who cannot join

  • Patients with GOG performance grade of 3 or 4
  • Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus
  • Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
  • Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
  • Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago
  • Patients with a life expectancy of less than one year
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  • Patients with body mass index (BMI) < 20 kg/m^2
  • Vegan vegetarians
  • Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue
  • Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months
  • Patients who have had surgery for weight loss
  • Note: women will not be excluded if their baseline lifestyle assessment indicates a healthy eating and moderate physical activity with the exception of the exclusion criteria above

Trial locations and contacts

687 sites in 1 country.

300 sites in 1 country

United States300 sites, 242 recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

    Mark S. Shahin, 215-481-2402

    Mark S. Shahin

    Recruiting

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

    Suspended

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

    Suspended

  • Southwest Gynecologic Oncology Associates Inc

    Albuquerque, New Mexico, 87106

    Suspended

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Philip J. Stella, 734-712-4673

    Philip J. Stella

    Recruiting

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

    Craig R. Nichols, 253-403-2394

    Craig R. Nichols

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

    Terminated

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

    Philip J. Stella, 734-712-4673

    Philip J. Stella

    Recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Suspended

  • Randolph Hospital

    Asheboro, North Carolina, 27203

    Vinay K. Gudena, 336-832-0821

    Vinay K. Gudena

    Recruiting

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

    Timothy J. Vanderkwaak, 412-339-5294, Roster@nrgoncology.org

    Timothy J. Vanderkwaak

    Recruiting

  • Piedmont Hospital

    Atlanta, Georgia, 30309

    Suspended

  • Northside Hospital

    Atlanta, Georgia, 30342

    Guilherme Henrique C. Cantuaria, 404-303-3355

    Guilherme Henrique C. Cantuaria

    Recruiting

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

    Stacy D. D'Andre, 415-209-2686, bernicl@sutterhealth.org

    Stacy D. D'Andre

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

    Stacy D. D'Andre, 415-209-2686, bernicl@sutterhealth.org

    Stacy D. D'Andre

    Recruiting

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

    John A. Keech, 907-458-5380

    John A. Keech

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Sharad A. Ghamande, 706-721-1663, cancer@augusta.edu

    Sharad A. Ghamande

    Recruiting

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

    Suspended

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Saketh R. Guntupalli, 720-848-0650

    Saketh R. Guntupalli

    Recruiting

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

    Maria T. Grosse-Perdekamp, 630-978-6212, Cancer.Research@rushcopley.com

    Maria T. Grosse-Perdekamp

    Recruiting

  • Virginia Mason Bainbridge Island Medical Center

    Bainbridge Island, Washington, 98110

    John A. Keech, 907-458-5380

    John A. Keech

    Recruiting

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Paul Celano, 443-849-3706

    Paul Celano

    Recruiting

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Hematology/Oncology Clinic LLP

    Baton Rouge, Louisiana, 70809

    Suspended

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

    M. G. Fort, 412-339-5294, Roster@nrgoncology.org

    M. G. Fort

    Recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Kathleen J. Yost, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen J. Yost

    Recruiting

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

    John A. Keech, 907-458-5380

    John A. Keech

    Recruiting

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

    Maria C. Bell, 218-333-5000

    Maria C. Bell

    Recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

    Stacy D. D'Andre, 415-209-2686, bernicl@sutterhealth.org

    Stacy D. D'Andre

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

    Chad A. Hamilton, 301-319-2100

    Chad A. Hamilton

    Recruiting

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

    Nicholas P. Taylor, 412-339-5294, Roster@nrgoncology.org

    Nicholas P. Taylor

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Philip J. Stella, 734-712-4673

    Philip J. Stella

    Recruiting

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

    Suspended

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Saint Vincent Healthcare

    Billings, Montana, 59101

    Suspended

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

    Benjamin T. Marchello, 800-648-6274

    Benjamin T. Marchello

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Warner K. Huh, 412-339-5294, Roster@nrgoncology.org

    Warner K. Huh

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Maria C. Bell, 218-333-5000

    Maria C. Bell

    Recruiting

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

    Suspended

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Philip J. Stella, 734-712-4673

    Philip J. Stella

    Recruiting

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Central Care Cancer Center-Carrie J Babb Cancer Center

    Bolivar, Missouri, 65613

    Active, not recruiting

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Young B. Kim, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org

    Young B. Kim

    Recruiting

  • Boulder Community Hospital

    Boulder, Colorado, 80301

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

    Suspended

  • Harrison Medical Center

    Bremerton, Washington, 98310

    Suspended

  • Ocean Medical Center

    Brick, New Jersey, 08724

    Suspended

  • Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

    Paul E. Berard, 412-339-5294, Roster@nrgoncology.org

    Paul E. Berard

    Recruiting

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

    Mehmet S. Copur, 308-398-6518, clinicaltrials@sfmc-gi.org

    Mehmet S. Copur

    Recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

    Mehmet S. Copur, 308-398-6518, clinicaltrials@sfmc-gi.org

    Mehmet S. Copur

    Recruiting

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

    Stacy D. D'Andre, 415-209-2686, bernicl@sutterhealth.org

    Stacy D. D'Andre

    Recruiting

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

    Corrine L. Zarwan, 781-744-8027

    Corrine L. Zarwan

    Recruiting

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

    Vinay K. Gudena, 336-832-0821

    Vinay K. Gudena

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Suspended

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Elizabeth L. Dickson Michelson, 414-649-5717

    Elizabeth L. Dickson Michelson

    Recruiting

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

    Jessica A. Thomes Pepin, 952-993-1517, mmcorc@healthpartners.com

    Jessica A. Thomes Pepin

    Recruiting

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

    Active, not recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    David P. Warshal, 856-325-6757

    David P. Warshal

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

    Stacy D. D'Andre, 415-209-2686, bernicl@sutterhealth.org

    Stacy D. D'Andre

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Michael P. Hopkins, 888-293-4673

    Michael P. Hopkins

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Caro Cancer Center

    Caro, Michigan, 48723

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

    Suspended

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

    Stacy D. D'Andre, 510-537-1234

    Stacy D. D'Andre

    Recruiting

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

    Craig R. Nichols, 253-403-2394

    Craig R. Nichols

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

    Shaker R. Dakhil, 316-268-5374

    Shaker R. Dakhil

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Linda Van Le, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Linda Van Le

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Whitney S. Graybill, 843-792-9321

    Whitney S. Graybill

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Suspended

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    John M. McDonald, 704-384-5369

    John M. McDonald

    Recruiting

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

    John M. McDonald, 704-342-9577

    John M. McDonald

    Recruiting

  • Southern Oncology Specialists-Charlotte

    Charlotte, North Carolina, 28262

    John M. McDonald, 412-339-5294, Roster@nrgoncology.org

    John M. McDonald

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Susan C. Modesitt, 859-257-3379

    Susan C. Modesitt

    Recruiting

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

    Suspended

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Shohreh Shahabi, 312-695-1301, cancer@northwestern.edu

    Shohreh Shahabi

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Summer B. Dewdney, 312-942-5498, clinical_trials@rush.edu

    Summer B. Dewdney

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    John W. Moroney, 773-834-7424

    John W. Moroney

    Recruiting

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

    Anthony C. Evans, 800-347-0673

    Anthony C. Evans

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Providence Oncology and Hematology Care Southeast

    Clackamas, Oregon, 97015

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Active, not recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Suspended

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

    Peter G. Rose, 866-223-8100

    Peter G. Rose

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Peter G. Rose, 866-223-8100

    Peter G. Rose

    Recruiting

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

    Suspended

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

    Active, not recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    David M. O'Malley, 800-293-5066, Jamesline@osumc.edu

    David M. O'Malley

    Recruiting

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

    Babak Edraki, 925-674-2580

    Babak Edraki

    Recruiting

  • Carolinas HealthCare System NorthEast

    Concord, North Carolina, 28025

    Suspended

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Jessica A. Thomes Pepin, 952-993-1517, mmcorc@healthpartners.com

    Jessica A. Thomes Pepin

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Michiana Hematology Oncology PC-Crown Point

    Crown Point, Indiana, 46307

    Active, not recruiting

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

    Suspended

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Suspended

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Suspended

  • Danbury Hospital

    Danbury, Connecticut, 06810

    Suspended

  • Carle on Vermilion

    Danville, Illinois, 61832

    Maria T. Grosse-Perdekamp, 412-339-5294, Roster@nrgoncology.org

    Maria T. Grosse-Perdekamp

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Radhika P. Gogoi, 570-271-5251

    Radhika P. Gogoi

    Recruiting

  • Sutter Davis Hospital

    Davis, California, 95616

    John K. Chan, 877-827-3222

    John K. Chan

    Recruiting

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Dekalb Medical Center

    Decatur, Georgia, 30033

    Sharad A. Ghamande, 706-721-1663, cancer@augusta.edu

    Sharad A. Ghamande

    Recruiting

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    John P. Kuebler, 614-488-2745, sheree@columbusccop.org

    John P. Kuebler

    Recruiting

  • Porter Adventist Hospital

    Denver, Colorado, 80210

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Rose Medical Center

    Denver, Colorado, 80220

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Colorado Cancer Research Program NCORP

    Denver, Colorado, 80222

    Keren Sturtz, 303-777-2663, kgeisen@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Suspended

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

    Philip J. Stella, 734-712-4673

    Philip J. Stella

    Recruiting

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

    Shaker R. Dakhil, 316-268-5374

    Shaker R. Dakhil

    Recruiting

  • Wentworth-Douglass Hospital

    Dover, New Hampshire, 03820

    Henry L. Sonneborn, 603-740-2150

    Henry L. Sonneborn

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Mihaela C. Cristea, 800-826-4673, becomingapatient@coh.org

    Mihaela C. Cristea

    Recruiting

  • Mercy Medical Center

    Durango, Colorado, 81301

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Southwest Oncology PC

    Durango, Colorado, 81301

    Mehmet S. Copur, 308-398-6518, clinicaltrials@sfmc-gi.org

    Mehmet S. Copur

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Laura J. Havrilesky, 888-275-3853

    Laura J. Havrilesky

    Recruiting

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

    Jeffrey W. Elder, 864-679-3966

    Jeffrey W. Elder

    Recruiting

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China Township, Michigan, 48054

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Marshfield Clinic Cancer Center - Eau Claire

    Eau Claire, Wisconsin, 54701

    Anthony C. Evans, 800-924-8515

    Anthony C. Evans

    Recruiting

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

    Active, not recruiting

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

    Jack B. Basil, 859-301-5473, darla.hehman@stelizabeth.com

    Jack B. Basil

    Recruiting

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

    Jessica A. Thomes Pepin, 952-993-1517, mmcorc@healthpartners.com

    Jessica A. Thomes Pepin

    Recruiting

  • Swedish Medical Center-Edmonds

    Edmonds, Washington, 98026

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Maria T. Grosse-Perdekamp, 217-383-3233, Research@carle.com

    Maria T. Grosse-Perdekamp

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

    Shaker R. Dakhil, 316-268-5374

    Shaker R. Dakhil

    Recruiting

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

    Active, not recruiting

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

    Active, not recruiting

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

    Active, not recruiting

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Comprehensive Cancer Care and Research Institute of Colorado LLC

    Englewood, Colorado, 80113

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Swedish Medical Center

    Englewood, Colorado, 80113

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

    John A. Keech, 907-458-5380

    John A. Keech

    Recruiting

  • Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Maria C. Bell, 218-333-5000

    Maria C. Bell

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Maria C. Bell, 218-333-5000

    Maria C. Bell

    Recruiting

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

    Maria C. Bell, 218-333-5000

    Maria C. Bell

    Recruiting

  • University of Connecticut

    Farmington, Connecticut, 06030

    Molly A. Brewer, 800-579-7822

    Molly A. Brewer

    Recruiting

  • Farmington Health Center

    Farmington, Utah, 84025

    Theresa L. Werner, 801-581-4477, clinical.trials@hci.utah.edu

    Theresa L. Werner

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Suspended

  • Virginia Mason Federal Way Medical Center

    Federal Way, Washington, 98002

    John A. Keech, 907-458-5380

    John A. Keech

    Recruiting

  • Saint Francis Hospital

    Federal Way, Washington, 98003

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Philip J. Stella, 734-712-4673

    Philip J. Stella

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Philip J. Stella, 734-712-4673

    Philip J. Stella

    Recruiting

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

    Elizabeth L. Dickson Michelson, 414-649-5717

    Elizabeth L. Dickson Michelson

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Diana C. Medgyesy, 970-297-6150

    Diana C. Medgyesy

    Recruiting

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

    Caela R. Miller, 210-916-4837

    Caela R. Miller

    Recruiting

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

    Shaker R. Dakhil, 316-268-5374

    Shaker R. Dakhil

    Recruiting

  • Baylor All Saints Medical Center at Fort Worth

    Fort Worth, Texas, 76104

    Terminated

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

    Stacy D. D'Andre, 415-209-2686, bernicl@sutterhealth.org

    Stacy D. D'Andre

    Recruiting

  • Unity Hospital

    Fridley, Minnesota, 55432

    Jessica A. Thomes Pepin, 952-993-1517, mmcorc@healthpartners.com

    Jessica A. Thomes Pepin

    Recruiting

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

    Carlton L. Schwab, 800-486-5941

    Carlton L. Schwab

    Recruiting

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

    Suspended

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Suspended

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Elizabeth L. Dickson Michelson, 414-649-5717

    Elizabeth L. Dickson Michelson

    Recruiting

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

    Mark A. Miller, 877-441-7957

    Mark A. Miller

    Recruiting

  • Tacoma/Valley Radiation Oncology Centers-Gig Harbor

    Gig Harbor, Washington, 98332

    John A. Keech, 907-458-5380

    John A. Keech

    Recruiting

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

    John A. Keech, 907-458-5380

    John A. Keech

    Recruiting

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Elizabeth L. Dickson Michelson, 414-649-5717

    Elizabeth L. Dickson Michelson

    Recruiting

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

    Terminated

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

    Kathleen J. Yost, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen J. Yost

    Recruiting

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

    Kathleen J. Yost, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen J. Yost

    Recruiting

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • North Colorado Medical Center

    Greeley, Colorado, 80631

    Keren Sturtz, 303-777-2663, ccrp@co-cancerresearch.org

    Keren Sturtz

    Recruiting

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

    Jonathan E. Tammela, 920-433-8889, Christy.Gilchrist@hshs.org

    Jonathan E. Tammela

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Matthew L. Ryan, 920-433-8889, Christy.Gilchrist@hshs.org

    Matthew L. Ryan

    Recruiting

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

    Jonathan E. Tammela, 920-433-8889, Christy.Gilchrist@hshs.org

    Jonathan E. Tammela

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Matthew L. Ryan, 920-433-8889, Christy.Gilchrist@hshs.org

    Matthew L. Ryan

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Elizabeth L. Dickson Michelson, 414-649-5717

    Elizabeth L. Dickson Michelson

    Recruiting

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

    Vinay K. Gudena, 336-832-0821

    Vinay K. Gudena

    Recruiting

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

    Jeffrey W. Elder, 864-679-3966

    Jeffrey W. Elder

    Recruiting

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

    Jeffrey W. Elder, 864-679-3966

    Jeffrey W. Elder

    Recruiting

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

    Jeffrey W. Elder, 864-679-3966

    Jeffrey W. Elder

    Recruiting

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

    Active, not recruiting

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

    Suspended

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

    Jeffrey W. Elder, 864-679-3966

    Jeffrey W. Elder

    Recruiting

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

    Carlton L. Schwab, 800-486-5941

    Carlton L. Schwab

    Recruiting

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Lymphoma Clinic of Michigan

    Grosse Pointe Woods, Michigan, 48236

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Michigan Breast Specialists-Grosse Pointe Woods

    Grosse Pointe Woods, Michigan, 48236

    J. R. Liu, 208-367-7954

    J. R. Liu

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Suspended

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Suspended

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Elena S. Ratner, 203-785-5702

    Elena S. Ratner

    Recruiting

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

    Radhika P. Gogoi, 570-271-5251

    Radhika P. Gogoi

    Recruiting

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Sudarshan K Sharma MD Limted-Gynecologic Oncology

    Hinsdale, Illinois, 60521

    Sudarshan K. Sharma, 630-654-1790, info@hhoaltd.com

    Sudarshan K. Sharma

    Recruiting

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

    Michael E. Carney, 808-586-2979

    Michael E. Carney

    Recruiting

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

    Michael E. Carney, 808-586-2979

    Michael E. Carney

    Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

    Michael E. Carney, 808-586-2979

    Michael E. Carney

    Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Michael E. Carney, 808-586-2979

    Michael E. Carney

    Recruiting

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

    Suspended

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Karen H. Lu, 713-792-3245

    Karen H. Lu

    Recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

    Active, not recruiting

  • The Methodist Hospital System

    Houston, Texas, 77030

    Aparna A. Kamat, 713-790-2700

    Aparna A. Kamat

    Recruiting

  • Methodist Willowbrook Hospital

    Houston, Texas, 77070

    Aparna A. Kamat, 713-790-2700

    Aparna A. Kamat

    Recruiting

  • Lake Norman Hematology Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

    John M. McDonald, 412-339-5294, Roster@nrgoncology.org

    John M. McDonald

    Recruiting

  • Presbyterian Hospital Huntersville

    Huntersville, North Carolina, 28078

    John M. McDonald, 704-384-5369

    John M. McDonald

    Recruiting

  • Southern Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

    John M. McDonald, 412-339-5294, Roster@nrgoncology.org

    John M. McDonald

    Recruiting

  • Tennessee Valley Gynecologic Oncology

    Huntsville, Alabama, 35805

    Suspended

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

    Suspended

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

    Shaker R. Dakhil, 316-268-5374

    Shaker R. Dakhil

    Recruiting

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

    Active, not recruiting

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Jeanne M. Schilder, 317-630-7808

    Jeanne M. Schilder

    Recruiting

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

    Michael J. Callahan, 317-338-2194, research@stvincent.org

    Michael J. Callahan

    Recruiting

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

    Scott E. Lentz, 626-564-3455

    Scott E. Lentz

    Recruiting

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Allegiance Health

    Jackson, Michigan, 49201

    Suspended

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

    Donald P. Seago, 601-200-3300

    Donald P. Seago

    Recruiting

  • Queens Hospital Center

    Jamaica, New York, 11432

    Suspended

  • Capital Region Medical Center-Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

    James L. Wade, 309-243-3605

    James L. Wade

    Recruiting

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

    Suspended

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Suspended

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Kathleen J. Yost, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen J. Yost

    Recruiting

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

    Benjamin T. Marchello, 406-969-6060, mccinfo@mtcancer.org

    Benjamin T. Marchello

    Recruiting

  • Providence Medical Center

    Kansas City, Kansas, 66112

    Suspended

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Andrea D. Jewell, 913-945-7552, ctnursenav@kumc.edu

    Andrea D. Jewell

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Active, not recruiting

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

    Active, not recruiting

  • Research Medical Center

    Kansas City, Missouri, 64132

    Active, not recruiting

  • Heartland Hematology and Oncology

    Kearney, Nebraska, 68845

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

    Mehmet S. Copur, 501-622-2100

    Mehmet S. Copur

    Recruiting

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Benjamin B. Bridges, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Benjamin B. Bridges

    Recruiting

  • Northwest Cancer Clinic

    Kennewick, Washington, 99336

    Suspended

Other trials in United States

About this study

Official title: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?

This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if women who are disease-free after successfully completing primary and potential consolidation/maintenance, therapy for stage II-IV ovarian, fallopian tube or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention, will have significantly increased progression-free survival compared to similar women who are randomized to a usual care comparison group.

SECONDARY OBJECTIVES:

  1. To determine if women who are randomized to the study intervention will have improved general quality of life as measured by the General Health subscale of Research and Development (RAND) 36-Item Health Survey (RAND-36).

II. To determine if women who are randomized to the study intervention will have improved physical and bowel functioning as measured by the Physical Functioning subscale of RAND-36 and the Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS), compared to women who are randomized to usual care.

TERTIARY OBJECTIVES:

  1. To assess patient compliance with the healthy lifestyle intervention by analyzing biomarkers (e.g., total carotenoid) at baseline, 6, 12, and 24 months.

II. To explore the relationship between carotenoid exposure and progression free survival from ovarian cancer.

III. To examine patient compliance with the healthy lifestyle intervention and to assess which types of patients are more likely to be compliant with the healthy lifestyle intervention and whether progression-free survival is better among compliant individuals.

IV. To explore the impact of the intervention on other aspects of quality of life such as pain, role limitations due to physical health and emotional problems, mental health, vitality, and social functioning as measured by the corresponding subscales of the RAND-36.

  1. To explore the impact of the intervention on bowel functioning as measured with the GSRS-IBS subscales.

VI. To assess the association between subjectively measured sleep duration/quality (using the Pittsburgh Sleep Quality Scale), anthropometric measurements, and self-reported dietary energy intake among women previously treated for stage II-IV ovarian or primary peritoneal cancer.

VII. To assess and compare telomere length and rate of telomere shortening between ovarian cancer survivors randomized to lifestyle intervention versus standard of care.

VIII. To assess effects of the intervention on biomarkers of metabolic health as measured by changes in circulating insulin and related insulin resistance, lipids and inflammation.

IX. To determine if the intervention effect on the biomarkers listed above is modified by baseline central adiposity.

  1. To determine if the intervention effect on biomarkers listed above is mediated by change in central adiposity.

XI. To evaluate changes in central adiposity using computerized tomography (CT) scan data from regularly scheduled, routine surveillance CT scans to determine if change in CT-specific visceral adiposity is associated with changes in biomarkers of metabolic deregulation and inflammation in a random subsample.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP 1 (LIFESTYLE INTERVENTION): Participants receive a dietary intervention designed to promote increased levels of plasma carotenoids, control weight, and to ensure adequacy of micronutrient intake. Participants also undergo a physical activity intervention comprising a moderately low aerobic regimen to raise the usual activity level. Participants also undergo face-to-face counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor twice a week for 4 weeks, then weekly for 2 weeks, twice a month for 5 months, monthly for the subsequent 6 months, and then once every other month for 12 months. Participants complete daily fat gram and step diaries at least three times per week.

GROUP 2 (COMPARISON LIFESTYLE): Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention).

After completion of study, participants are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Being tested
Behavioral Dietary Intervention, Compliance Monitoring, Counseling, Educational Intervention, Exercise Intervention
Medical subject headings
Brenner Tumor, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Dietary InterventionBehavioural

    Receive dietary intervention

  • Compliance MonitoringBehavioural

    Complete daily fat gram and step diaries

  • CounselingOther

    Also called Counseling Intervention

    Undergo face-to-face and telephone counseling

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive educational materials

  • Exercise InterventionBehavioural

    Undergo physical activity intervention

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT00719303
Study groupRoleWhat they receive
Group I (lifestyle intervention)ExperimentalParticipants receive a dietary intervention designed to promote increased levels of plasma carotenoids, control weight, and to ensure adequacy of micronutrient intake. Participants also undergo a physical activity intervention comprising a moderately low aerobic regimen to raise the usual activity level. Participants also undergo face-to-face counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor twice a week for 4 weeks, then weekly for 2 weeks, twice a month for 5 months, monthly for the subsequent 6 months, and then once every other month for 12 months. Participants complete daily fat gram and step diaries at least three times per week.
Receives: Behavioral: Behavioral Dietary Intervention; Behavioral: Compliance Monitoring; Other: Counseling; Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (observation)Active comparatorParticipants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention).
Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no).

    Measured: From entry onto the protocol to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 9 years

Secondary outcomes (2)

  1. Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS

    Linear mixed effects models for repeated measures will be fitted to general health subscale score, physical functioning subscale score of RAND-36, and to GSRS-IBS overall score respectively.

    Measured: Baseline to up to 24 months

  2. Change in self-reported quality of life measured using RAND-36

    Linear mixed effects models for repeated measures will be fitted to general health subscale score, physical functioning subscale score of RAND-36, and to GSRS-IBS overall score respectively.

    Measured: Baseline to up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study start18 Jun 2012
  3. Primary completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,070 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00719303
Sponsor's protocol ID
GOG-0225
Other IDs
NCI-2009-00595, CDR0000594600, GOG-0225, GOG-0225, GOG-0225, U10CA101165, U10CA180830, UG1CA189867
Status last verified
Feb 2018
First submitted
18 Jul 2008
Last updated
19 Feb 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Thomson CA, Crane TE, Miller A, Gold MA, Powell M, Bixel K, Van Le L, DiSilvestro P, Ratner E, Lele S, Guntupalli S, Huh W, Robertson SE, Modesitt S, Casey AC, Basen-Engquist K, Skiba M, Walker J, Kachnic L, Alberts DS. Lifestyle intervention in ovarian cancer enhanced survival (LIVES) study (NRG/GOG0225): Recruitment, retention and baseline characteristics of a randomized trial of diet and physical activity in ovarian cancer survivors. Gynecol Oncol. 2023 Mar;170:11-18. doi: 10.1016/j.ygyno.2022.12.017. Epub 2023 Jan 4.

    PubMed 36608382

  • Thomson CA, Crane TE, Miller A, Garcia DO, Basen-Engquist K, Alberts DS. A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. Contemp Clin Trials. 2016 Jul;49:181-9. doi: 10.1016/j.cct.2016.07.005. Epub 2016 Jul 6.

    PubMed 27394382

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Behavioral Dietary Intervention, Compliance Monitoring and Counseling in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by Gynecologic Oncology Group at 687 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 687 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From entry onto the protocol to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 9 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00719303, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.

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