AzTrials
AzTrials

Esophageal CancerPhase 3NCT00052910

Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer

A Phase 3 study testing cisplatin, epirubicin hydrochloride and fluorouracil in people with Esophageal Cancer and Gastric Cancer, run by Alliance for Clinical Trials in Oncology at 535 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
cisplatin, epirubicin hydrochloride and fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
546 participants
Where
535 sitesin 2 countries
Study dates
Dec 2002to Dec 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Required Tumor Parameters 1.1 Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible. 1.2 Patients must have had en bloc resection of all known tumor. The surgical resection must have been done with a curative intent. 1.3 Patients must have tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease.
  • Patients can have stages IB if there is evidence of either node-positive (N1) disease or tumor extension beyond the muscularis propria (i.e., T1, N1, M0 patients are eligible but patients with T2, N0, M0 are allowed only if there is extension beyond the muscularis propria).
  • Patients can have stages II, IIIA, IIIB or stage IV with M0 (i.e., T4N2M0).
  • Stages 0, IA, or any stage with M1 are not allowed. (see Appendix I for TNM staging guide). 1.4 Patients with known unresected cancer, recurrent cancer, microscopic evidence of tumor at the distal or proximal line of stomach resection, noncontiguous resection of tumor, or M1 (metastatic) disease are ineligible.
  1. Prior Therapy 2.1 No prior therapy (except hormonal or biologic) for other malignancies is allowed except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years. 2.2 Patients who have had any previous chemotherapy or radiotherapy are ineligible.
  2. Patient Characteristics 3.1 Patients must have an ECOG (CTC) performance status of 0, 1 or 2. 3.2 Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical body weight. Patients must have documentation of stable weight (or less than 2 pounds weight loss) for at least one week prior to registration. 3.3 All patients must be evaluated by a radiation oncologist (prior to enrollment) to ensure that the patient is an appropriate candidate for radiation therapy. 3.4 Patients may not have unilateral renal function (only one functioning kidney) as determined by CT scan with contrast, urogram, renal scan, or other study. 3.5 Pregnant or lactating women may not participate. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method or practice abstinence while in this study.
  • The effects of therapeutic radiotherapy are known to be teratogenic.
  • The effects of Epirubicin, Cisplatin, and 5-FU on a developing human fetus at the recommended therapeutic dose are less well known.
  • For this reason and because DNA alkylating agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
  • Should a woman become pregnant or suspect she is pregnant while participating on this study, she should inform her treating physician immediately. Because the risk of toxicity in nursing infants secondary to Epirubicin, Cisplatin, and 5-FU treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued. 3.6 Patients with any of the following cardiac conditions are ineligible:
  • Uncontrolled high blood pressure
  • Unstable angina
  • Symptomatic congestive heart failure
  • Myocardial infarction < 6 months prior to registration
  • Serious uncontrolled cardiac arrhythmia
  • New York Heart Association classification III or IV. 3.7 No uncontrolled serious medical or psychiatric illness which would prevent compliance with treatment or adequate informed consent. 3.8 Patients with active infectious process are ineligible. 3.9 Patients with grade 2 or greater peripheral neuropathy at baseline are ineligible.
  1. Required Initial Laboratory Values:
  • Granulocytes ≥ 1,500/μl
  • Platelet count ≥ 100,000/μl
  • Creatinine ≤ 1.5 mg/dl
  • Bilirubin ≤ 2.0 mg/dl
  • AST ≤ 3x upper limits of normal

Trial locations and contacts

535 sites in 2 countries.

308 sites in 2 countries

United States300 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Study site

    Alexandria, Minnesota, 56308

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Regional Medical Center

    Anniston, Alabama, 36202

  • Kaiser Permanente - Deer Valley

    Antioch, California, 94531

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Pennington Cancer Center at Baton Rouge General

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center - Bluebonnet

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • UPMC Cancer Center at Beaver Medical Center

    Beaver, Pennsylvania, 15009

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Hematology Oncology Associates of Illinois - Berwyn

    Berwyn, Illinois, 60402

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

    Boca Raton, Florida, 33486

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Tufts-NEMC Cancer Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Caritas St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135-2997

  • Blue Ridge Medical Specialists, PC

    Bristol, Tennessee, 37620

  • Kings County Hospital Center

    Brooklyn, New York, 11203

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25304

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • UPMC Cancer Center at Jefferson Regional Medical Center

    Clairton, Pennsylvania, 15025

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Memorial Hospital Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80909

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Ochsner Health Center - Covington

    Covington, Louisiana, 70433

  • Hematology and Oncology Associates of Rhode Island

    Cranston, Rhode Island, 02920

  • Praxair Cancer Center at Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center

    DuBois, Pennsylvania, 15801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Shore Regional Cancer Center at Memorial Hospital - Easton

    Easton, Maryland, 21601

  • Easton Regional Cancer Center at Easton Hospital

    Easton, Pennsylvania, 18042

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • St. Anthony's Memorial Hospital

    Effingham, Illinois, 62401

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • Dakota Cancer Institute at Dakota Clinic - South University

    Fargo, North Dakota, 58103

  • Study site

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Valley Medical Oncology

    Fremont, California, 94538

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • UPMC Cancer Center - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Virginia Oncology Associates - Hampton

    Hampton, Virginia, 23666

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hattiesburg Clinic, PA at Forrest General

    Hattiesburg, Mississippi, 39401

  • Hematology & Oncology Clinic

    Hattiesburg, Mississippi, 39402

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Independence Regional Health Center

    Independence, Missouri, 64050

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • UPMC Cancer Center at the John P. Murtha Pavilion

    Johnstown, Pennsylvania, 15901

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401-9320

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Associates in Oncology and Hematology

    Kensington, Maryland, 20895

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Center for Cancer Care and Research at Watson Clinic, LLP

    Lakeland, Florida, 33805

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • St. Mary Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cleo Craig Cancer Research Clinic

    Lawton, Oklahoma, 73505

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Liberty Hospital

    Liberty, Missouri, 64068

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center Cancer Center

    Livingston, New Jersey, 07039

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Lynchburg Hematology-Oncology Clinic

    Lynchburg, Virginia, 24501

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Riddle Memorial Hospital Cancer Center

    Media, Pennsylvania, 19063

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Memorial Medical Center

    Modesto, California, 95355

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

    Monterey, California, 93940

  • UPMC - Moon

    Moon Township, Pennsylvania, 15108

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Camino Medical Group - Treatment Center

    Mountain View, California, 94040

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Medical Consultants, PC at Ball Memorial Cancer Center

    Muncie, Indiana, 47303

  • Community Hospital

    Munster, Indiana, 46321

Other trials in United States

Canada8 sites

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 1C4

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.

Read the detailed description

OBJECTIVES:

  • Compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin, and infusional fluorouracil (5-FU) vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy.
  • Compare disease-free survival and local and distant recurrence rates in these patients treated with these regimens.
  • Correlate the expression of putative prognostic markers (including TS, ERCC-1, MSI, E-cadherin, EGFR, p27, COX-2, and c-erbB-2) with overall survival of patients treated with these regimens.
  • Correlate specific germline polymorphisms related to chemotherapy metabolism and resistance (including UGT2B7 [epirubicin], GST [cisplatin], ERCCI [cisplatin], XRCC1 [cisplatin], TS [5-FU], DPD [5-FU], and EGFR polymorphisms) with treatment-related toxicity and overall survival of these patients.
  • Correlate serum levels of insulin-like growth factor-1 (IGF-1), IGF-2, and IGF-binding protein 3 with overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days between course 2 and 3.
  • Arm II: Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 824 patients will be accrued for this study.

Being tested
cisplatin, epirubicin hydrochloride, fluorouracil, leucovorin calcium, radiation therapy
Keywords
stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

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

Study groups in NCT00052910
Study groupRoleWhat they receive
Arm IActive comparatorPatients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
Receives: Drug: fluorouracil; Drug: leucovorin calcium; Radiation: radiation therapy
Arm IIExperimentalPatients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Receives: Drug: cisplatin; Drug: epirubicin hydrochloride; Drug: fluorouracil; Radiation: radiation therapy

What is being measured

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

  1. Overall Survival

    Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: From study enrollment until death from any cause; up to 3 years

Secondary outcomes (1)

  1. Disease Free Survival

    Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.

    Measured: From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 2002
  3. Primary completionJun 2012
  4. Study completionDec 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052910
Sponsor's protocol ID
CALGB-80101
Other IDs
U10CA031946, CDR0000258787
Status last verified
Apr 2020
First submitted
24 Jan 2003
Last updated
7 May 2020
Data monitoring committee
Yes

Publications

  • Fuchs C, Tepper JE, Niedwiecki D, et al.: Postoperative adjuvant chemoradiation for gastric or gastroesophageal adenocarcinoma using epirubicin, cisplatin, and infusional (CI) 5-FU (ECF) before and after CI 5-FU and radiotherapy (RT): interim toxicity results from Intergroup trial CALGB 80101. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-61, 2006.

  • Patel JN, Jiang C, Owzar K, Mulkey F, Luzum JA, Mamon HJ, Haller DG, Dragovich T, Alberts SR, Bjarnason G, Willet CG, Niedzwiecki D, Enzinger P, Ratain MJ, Fuchs C, McLeod HL. Pharmacogenetic study in gastric cancer patients treated with adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil before and after chemoradiation on CALGB 80101 (Alliance). Pharmacogenet Genomics. 2021 Dec 1;31(9):215-220. doi: 10.1097/FPC.0000000000000442.

    PubMed 34149004

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, epirubicin hydrochloride and fluorouracil in people with Esophageal Cancer and Gastric Cancer, run by Alliance for Clinical Trials in Oncology at 535 sites in 2 countries.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 535 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From study enrollment until death from any cause; up to 3 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 NCT00052910, 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 7 May 2020.

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