Stage I Ovarian Cancer AJCC v6 and v7NCT01366183
Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
An observational study of Stage I Ovarian Cancer AJCC v6 and v7 and Stage IA Fallopian Tube Cancer AJCC v6 and v7, run by Gynecologic Oncology Group at 357 sites in United States.
Trial summary
This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Stage I Ovarian Cancer AJCC v6 and v7, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7
- What is being tested?
- Assessment of Therapy Complications, Carboplatin and Filgrastim
- Type of treatment
- Surgery or procedure
- How many people
- 290 participants
- Where
- 357 sitesUnited States
- Study dates
- 15 Aug 2011to 31 Dec 2021
- Phase
- Observational
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only
- International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible
- Patients must have received no previous treatment for this malignancy other than surgery
- Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
Show all 15Show fewer
- Bilirubin less than or equal upper limit of normal (ULN)
- Creatinine less than or equal to 1.5 x ULN
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3
- Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013)
- Patients must have recovered from the effects of recent surgery
- Patients must be free of active infection requiring antibiotics
- Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA)
- Patient and physician agree that they plan to conduct treatment according to Regimen 3
- Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments
Who cannot join
- Patients who have received previous treatment for this malignancy other than surgery
- Patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy
- ?Borderline tumors? (tumors of low malignant potential) by surgery or biopsy are excluded
- Patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe should be excluded
Trial locations and contacts
357 sites in 1 country.
300 sites in 1 country
United States300 sites
Summa Health System - Akron Campus
Akron, Ohio, 44304
Cleveland Clinic Akron General
Akron, Ohio, 44307
Women's Cancer Care Associates LLC
Albany, New York, 12208
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic PC - Ames
Ames, Iowa, 50010
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Augusta University Medical Center
Augusta, Georgia, 30912
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Eastern Maine Medical Center
Bangor, Maine, 04401
Woman's Hospital
Baton Rouge, Louisiana, 70817
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Montana Cancer Consortium NCORP
Billings, Montana, 59102
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
McFarland Clinic PC-Boone
Boone, Iowa, 50036
Boston Medical Center
Boston, Massachusetts, 02118
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
State University of New York Downstate Medical Center
Brooklyn, New York, 11203
Roswell Park Cancer Institute
Buffalo, New York, 14263
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
University of Vermont Medical Center
Burlington, Vermont, 05401
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Aultman Health Foundation
Canton, Ohio, 44710
Rocky Mountain Oncology
Casper, Wyoming, 82609
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Weiss Memorial Hospital
Chicago, Illinois, 60640
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Oncology Hematology Care Inc-Anderson
Cincinnati, Ohio, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Bethesda North Hospital
Cincinnati, Ohio, 45242
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242
Case Western Reserve University
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
John B Amos Cancer Center
Columbus, Georgia, 31904
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mount Carmel East Hospital
Columbus, Ohio, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Riverside Methodist Hospital
Columbus, Ohio, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215
Grant Medical Center
Columbus, Ohio, 43215
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
John Muir Medical Center-Concord Campus
Concord, California, 94520
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Mercy Hospital
Coon Rapids, Minnesota, 55433
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017
Danbury Hospital
Danbury, Connecticut, 06810
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Miami Valley Hospital North
Dayton, Ohio, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459
Beaumont Hospital - Dearborn
Dearborn, Michigan, 48124
Dekalb Medical Center
Decatur, Georgia, 30033
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Delaware Radiation Oncology
Delaware, Ohio, 43015
Grady Memorial Hospital
Delaware, Ohio, 43015
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Ascension Saint John Hospital
Detroit, Michigan, 48236
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
Duke University Medical Center
Durham, North Carolina, 27710
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
Saint Elizabeth Medical Center South
Edgewood, Kentucky, 41017
Fairview Southdale Hospital
Edina, Minnesota, 55435
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
Elkhart Clinic
Elkhart, Indiana, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, 80110
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Blanchard Valley Hospital
Findlay, Ohio, 45840
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Florida Gynecologic Oncology
Fort Myers, Florida, 33905
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Unity Hospital
Fridley, Minnesota, 55432
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
Glens Falls Hospital
Glens Falls, New York, 12801
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Wayne Hospital
Greenville, Ohio, 45331
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331
Hartford Hospital
Hartford, Connecticut, 06102
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Northern Montana Hospital
Havre, Montana, 59501
Saint Peter's Community Hospital
Helena, Montana, 59601
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, 60521
M D Anderson Cancer Center
Houston, Texas, 77030
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801
Allegiance Health
Jackson, Michigan, 49201
McFarland Clinic PC-Jefferson
Jefferson, Iowa, 50129
Jupiter Medical Center
Jupiter, Florida, 33458
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Borgess Medical Center
Kalamazoo, Michigan, 49048
Glacier Oncology PLLC
Kalispell, Montana, 59901
Kalispell Medical Oncology
Kalispell, Montana, 59901
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Providence Medical Center
Kansas City, Kansas, 66112
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
North Kansas City Hospital
Kansas City, Missouri, 64116
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118
Research Medical Center
Kansas City, Missouri, 64132
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920
Community Howard Regional Health
Kokomo, Indiana, 46904
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
UC San Diego Moores Cancer Center
La Jolla, California, 92093
IU Health La Porte Hospital
La Porte, Indiana, 46350
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Fairfield Medical Center
Lancaster, Ohio, 43130
Lancaster Radiation Oncology
Lancaster, Ohio, 43130
Sparrow Hospital
Lansing, Michigan, 48912
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086
Beebe Medical Center
Lewes, Delaware, 19958
Baptist Health Lexington
Lexington, Kentucky, 40503
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905
Liberty Radiation Oncology Center
Liberty, Missouri, 64068
Saint Mary Mercy Hospital
Livonia, Michigan, 48154
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
North Shore University Hospital
Manhasset, New York, 11030
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Marietta Memorial Hospital
Marietta, Ohio, 45750
Bay Area Medical Center
Marinette, Wisconsin, 54143
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, 50158
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
Mercy Hospital
Miami, Florida, 33133
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Middlesex Hospital
Middletown, Connecticut, 06457
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Cancer Care Partners LLC
Mishawaka, Indiana, 46545
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545
Montana Cancer Specialists
Missoula, Montana, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Monongalia Hospital
Morgantown, West Virginia, 26505
Virtua Memorial
Mount Holly, New Jersey, 08060
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
Knox Community Hospital
Mount Vernon, Ohio, 43050
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Yale University
New Haven, Connecticut, 06520
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
New Ulm Medical Center
New Ulm, Minnesota, 56073
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Christiana Gynecologic Oncology LLC
Newark, Delaware, 19713
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
Licking Memorial Hospital
Newark, Ohio, 43055
Newark Radiation Oncology
Newark, Ohio, 43055
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Saint Joseph Hospital - Orange
Orange, California, 92868
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Menorah Medical Center
Overland Park, Kansas, 66209
Saint Luke's South Hospital
Overland Park, Kansas, 66213
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, 85012
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563
Beth Israel Deaconess Hospital-Plymouth
Plymouth, Massachusetts, 02360
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341
Lake Huron Medical Center
Port Huron, Michigan, 48060
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124
Women and Infants Hospital
Providence, Rhode Island, 02905
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, 54501
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Reid Health
Richmond, Indiana, 47374
West Suburban Medical Center
River Forest, Illinois, 60305
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, 64507
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Cancer Center of Kansas - Salina
Salina, Kansas, 67401
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Memorial Health University Medical Center
Savannah, Georgia, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Welch Cancer Center
Sheridan, Wyoming, 82801
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Memorial Hospital of South Bend
South Bend, Indiana, 46601
About this study
Official title: Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether the score on Instrumental Activities of Daily Living (IADL) obtained prior to treatment is associated with the ability of patients to complete four cycles of chemotherapy without dose reduction or a more than 7-day delay.
II. To estimate by regimen the percentage of patients who are able to complete four cycles of chemotherapy regardless of dose reductions and delays.
III. To compare actual and calculated carboplatin area under the curve (AUC) in this patient population.
SECONDARY OBJECTIVES:
- To describe the percentage of patients who are entered after primary surgery versus those entered to receive primary or neoadjuvant chemotherapy, the percentage of patients who are treated with each allowed regimen, and the percentage of patients who eventually receive surgery in the primary chemotherapy group.
II. To determine whether the need for assistance with IADLs at time of registration is associated with choice of chemotherapy regimen (in both primary chemotherapy and primary surgery patients).
III. To explore whether age, baseline scores on the geriatric measures (functional status, nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with likelihood of completing four courses of chemotherapy without dose reduction or a more than 7-day delay.
IV. To explore reasons for and timing of dose reductions and delays. V. To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores on geriatric measures in this patient population.
TERTIARY OBJECTIVES:
- To explore potential relationships of carboplatin AUC, paclitaxel clearance, and paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and platelet counts during course 1 of treatment.
II. To explore the association between baseline IADL and survival. III. To explore the association between IADL and the functional well-being (FWB) subscale in the Functional Assessment of Cancer Therapy ? Ovary (FACT-O).
OUTLINE:
Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.
Patients' quality of life is assessed by the FACT-O, the Functional Assessment of Cancer Treatment ? Neurotoxicity (FACT-Ntx subscale), the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.
- Conditions
- Stage I Ovarian Cancer AJCC v6 and v7, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7, Stage IC Fallopian Tube Cancer AJCC v6 and v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7
- Being tested
- Assessment of Therapy Complications, Carboplatin, Filgrastim, Paclitaxel, Pharmacological Study
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Therapy ComplicationsProcedure or surgery
Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Undergo chemotherapy
FilgrastimBiological
Also called FILGRASTIM, LICENSE HOLDER UNSPECIFIED, G-CSF, Neupogen, r-metHuG-CSF
Undergo chemotherapy
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Undergo chemotherapy
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (quality of life questionnaire) | Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.
Patients' quality of life is assessed by the FACT-O, the FACT-Ntx subscale, the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed. Receives: Procedure: Assessment of Therapy Complications; Drug: Carboplatin; Biological: Filgrastim; Drug: Paclitaxel; Other: Pharmacological Study; 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.
Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days
Will be modeled with logistic regression using baseline IADL scores as a covariate. Exploratory analysis will evaluate baseline IADL scores adjusting for covariates such as: Charlson scale, nutritional status, or age.
Measured: Up to 5 years
Percent of women, who are 70 years or older, able to complete at least 4 cycles of treatment regardless of dose reduction and delays
While this percentage will be estimated for each study regimen separately, the targeted sample size will limit the width of the 95%-confidence interval for the marginal percentage so that it is no larger than 0.15.
Measured: Up to 5 years
Secondary outcomes (5)
Changes in quality-of-life measured by FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL
The changes in FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL will be summarized descriptively as the differences of scores between pre and post chemotherapy. Assuming 80% of patients complete the assessment at the completion of chemotherapy, then a sample of 148 patients will provide 90% power to detect 5 unit changes in FACT-O, 0.5 unit change in FACT/GOG-Ntx subscale score, 1 unit change in IADL or ADL score using paired t-test at significant level of 0.05.
Measured: Baseline to up to 6 weeks after completion of course 4
Changes in comorbidity index measured by the Charlson scale
Measured: Baseline to up to 6 weeks after completion of course 4
Changes in nutritional status measured by weight
The changes in weight will be summarized descriptively as the differences of scores between pre and post chemotherapy. The change of nutritional status after completing chemotherapy will be examined using McNemar?s test.
Measured: Baseline to up to 6 weeks after completion of course 4
Clinical response of elderly patients with ovarian, primary peritoneal cavity, or fallopian tube cancer
Measured: Up to 5 years
Percent of patients reporting adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events
The probability of an adverse event will be estimated as the percent of patients reporting an adverse event out of all patients beginning treatment.
Measured: Up to 6 weeks after course 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study start15 Aug 2011
- Primary completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Ovarian Cancer AJCC v6 and v7Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vivian E von Gruenigen, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366183
- Sponsor's protocol ID
- GOG-0273
- Other IDs
- NCI-2011-02900, GOG-0273, GOG-0273, GOG-0273, U10CA101165
- Status last verified
- Sep 2021
- First submitted
- 2 Jun 2011
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No