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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00052910
Other study ID # CALGB-80101
Secondary ID U10CA031946CDR00
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2002
Est. completion date December 2016

Study information

Verified date April 2020
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 546
Est. completion date December 2016
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

2. 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.

3. 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.

4. 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

Study Design


Intervention

Drug:
cisplatin
Given IV
epirubicin hydrochloride
Given IV
fluorouracil
Given IV
leucovorin calcium
Given IV
Radiation:
radiation therapy
Given 5 days a week for 5 weeks

Locations

Country Name City State
Canada Cross Cancer Institute at University of Alberta Edmonton Alberta
Canada Margaret and Charles Juravinski Cancer Centre Hamilton Ontario
Canada Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario
Canada London Regional Cancer Program at London Health Sciences Centre London Ontario
Canada Ottawa Hospital Regional Cancer Centre - General Campus Ottawa Ontario
Canada Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan
Canada Saint John Regional Hospital Saint John New Brunswick
Canada CancerCare Manitoba Winnipeg Manitoba
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States McDowell Cancer Center at Akron General Medical Center Akron Ohio
United States Summa Center for Cancer Care at Akron City Hospital Akron Ohio
United States Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany Georgia
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States American Fork Hospital American Fork Utah
United States McFarland Clinic, PC Ames Iowa
United States AnMed Cancer Center Anderson South Carolina
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Regional Medical Center Anniston Alabama
United States Kaiser Permanente - Deer Valley Antioch California
United States Mission Hospitals - Memorial Campus Asheville North Carolina
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Aurora Presbyterian Hospital Aurora Colorado
United States Rush-Copley Cancer Care Center Aurora Illinois
United States Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana
United States Ochsner Health Center - Bluebonnet Baton Rouge Louisiana
United States Pennington Cancer Center at Baton Rouge General Baton Rouge Louisiana
United States Battle Creek Health System Cancer Care Center Battle Creek Michigan
United States Bay Regional Medical Center Bay City Michigan
United States UPMC Cancer Center at Beaver Medical Center Beaver Pennsylvania
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States St. Joseph Cancer Center Bellingham Washington
United States Hematology Oncology Associates of Illinois - Berwyn Berwyn Illinois
United States St. Luke's Cancer Network at St. Luke's Hospital Bethlehem Pennsylvania
United States Hematology Oncology Associates of the Quad Cities Bettendorf Iowa
United States Mecosta County Medical Center Big Rapids Michigan
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Bismarck Cancer Center Bismarck North Dakota
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus Boca Raton Florida
United States Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston University Cancer Research Center Boston Massachusetts
United States Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts
United States Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts-NEMC Cancer Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Wood County Oncology Center Bowling Green Ohio
United States Olympic Hematology and Oncology Bremerton Washington
United States Caritas St. Elizabeth's Medical Center Brighton Massachusetts
United States Blue Ridge Medical Specialists, PC Bristol Tennessee
United States Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York
United States Kings County Hospital Center Brooklyn New York
United States SUNY Downstate Medical Center Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Veterans Affairs Medical Center - Buffalo Buffalo New York
United States Providence Saint Joseph Medical Center - Burbank Burbank California
United States Lahey Clinic Medical Center - Burlington Burlington Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Medical Center Castro Valley California
United States Valley Medical Oncology Consultants - Castro Valley Castro Valley California
United States Sandra L. Maxwell Cancer Center Cedar City Utah
United States Iowa Blood and Cancer Care Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States St. Luke's Hospital Cedar Rapids Iowa
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Roper St. Francis Cancer Center at Roper Hospital Charleston South Carolina
United States West Virginia University Health Sciences Center - Charleston Charleston West Virginia
United States Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States Creticos Cancer Center at Advocate Illinois Masonic Medical Center Chicago Illinois
United States Hematology and Oncology Associates Chicago Illinois
United States Resurrection Medical Center Chicago Illinois
United States Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago Westside Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States UPMC Cancer Center at Jefferson Regional Medical Center Clairton Pennsylvania
United States MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland Ohio
United States North Coast Cancer Care - Clyde Clyde Ohio
United States Memorial Hospital Cancer Center - Colorado Springs Colorado Springs Colorado
United States Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Ochsner Health Center - Covington Covington Louisiana
United States Hematology and Oncology Associates of Rhode Island Cranston Rhode Island
United States Praxair Cancer Center at Danbury Hospital Danbury Connecticut
United States Danville Regional Medical Center Danville Virginia
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States CCOP - Dayton Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Veterans Affairs Medical Center - Dayton Dayton Ohio
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Colorado Cancer Research Program Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - St. Luke's Medical Center Denver Colorado
United States Rose Medical Center Denver Colorado
United States St. Anthony Central Hospital Denver Colorado
United States St. Joseph Hospital Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Mercy Capitol Hospital Des Moines Iowa
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center DuBois Pennsylvania
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg Pennsylvania
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Easton Regional Cancer Center at Easton Hospital Easton Pennsylvania
United States Shore Regional Cancer Center at Memorial Hospital - Easton Easton Maryland
United States Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States John F. Kennedy Medical Center Edison New Jersey
United States St. Anthony's Memorial Hospital Effingham Illinois
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Union Hospital Cancer Program at Union Hospital Elkton Maryland
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Hematology Oncology Center Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology, Limited - Escanaba Escanaba Michigan
United States Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River Massachusetts
United States Dakota Cancer Institute at Dakota Clinic - South University Fargo North Dakota
United States Blanchard Valley Medical Associates Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Broward General Medical Center Cancer Center Fort Lauderdale Florida
United States Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Fort Smith Arkansas
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology, Incorporated Fredericksburg Virginia
United States CentraState Medical Center Freehold New Jersey
United States Kaiser Permanente - Fremont Fremont California
United States Valley Medical Oncology Fremont California
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Glendale Memorial Hospital Comprehensive Cancer Center Glendale California
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Altru Cancer Center at Altru Hospital Grand Forks North Dakota
United States St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado
United States Butterworth Hospital at Spectrum Health Grand Rapids Michigan
United States CCOP - Grand Rapids Grand Rapids Michigan
United States Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan
United States Big Sky Oncology Great Falls Montana
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States UPMC Cancer Center - Arnold Palmer Pavilion Greensburg Pennsylvania
United States CCOP - Greenville Greenville South Carolina
United States Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Virginia Oncology Associates - Hampton Hampton Virginia
United States Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut
United States Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey Illinois
United States Hattiesburg Clinic, PA at Forrest General Hattiesburg Mississippi
United States Hematology & Oncology Clinic Hattiesburg Mississippi
United States Northern Montana Hospital Havre Montana
United States Kaiser Permanente Medical Center - Hayward Hayward California
United States Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania
United States Veterans Affairs Medical Center - Hines Hines Illinois
United States Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida
United States Terrebonne General Medical Center Houma Louisiana
United States Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington West Virginia
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cape Cod Hospital Hyannis Massachusetts
United States Cancer Center of Kansas-Independence Independence Kansas
United States Independence Regional Health Center Independence Missouri
United States Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States William N. Wishard Memorial Hospital Indianapolis Indiana
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Dickinson County Healthcare System Iron Mountain Michigan
United States Foote Memorial Hospital Jackson Michigan
United States Baptist Cancer Institute - Jacksonville Jacksonville Florida
United States UPMC Cancer Center at the John P. Murtha Pavilion Johnstown Pennsylvania
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Midwest Center for Hematology/Oncology Joliet Illinois
United States Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center Jonesboro Arkansas
United States Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States CCOP - Kansas City Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Parvin Radiation Oncology Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States St. Joseph Medical Center Kansas City Missouri
United States Truman Medical Center - Hospital Hill Kansas City Missouri
United States Good Samaritan Cancer Center at Good Samaritan Hospital Kearney Nebraska
United States Columbia Basin Hematology Kennewick Washington
United States Associates in Oncology and Hematology Kensington Maryland
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport Tennessee
United States Kinston Medical Specialists Kinston North Carolina
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Howard Community Hospital Kokomo Indiana
United States La Grange Memorial Hospital La Grange Illinois
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Wilford Hall Medical Center Lackland Air Force Base Texas
United States Center for Cancer Care and Research at Watson Clinic, LLP Lakeland Florida
United States Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan
United States Fairfield Medical Center Lancaster Ohio
United States St. Mary Regional Cancer Center Langhorne Pennsylvania
United States Sparrow Regional Cancer Center Lansing Michigan
United States Doctor's Hospital of Laredo Laredo Texas
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cleo Craig Cancer Research Clinic Lawton Oklahoma
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Lewistown Hospital Lewistown Pennsylvania
United States Southwest Medical Center Liberal Kansas
United States Liberty Hospital Liberty Missouri
United States North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville Illinois
United States Lima Memorial Hospital Lima Ohio
United States St. Rita's Medical Center Lima Ohio
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States Meeker County Memorial Hospital Litchfield Minnesota
United States Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas
United States St. Barnabas Medical Center Cancer Center Livingston New Jersey
United States St. Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Hope Cancer Care Center at Longmont United Hospital Longmont Colorado
United States McKee Medical Center Loveland Colorado
United States Lowell General Hospital Lowell Massachusetts
United States Lynchburg Hematology-Oncology Clinic Lynchburg Virginia
United States Medical Center of Central Georgia Macon Georgia
United States Elliot Regional Cancer Center at Elliot Hospital Manchester New Hampshire
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Northwest Ohio Oncology Center Maumee Ohio
United States St. Luke's Hospital Maumee Ohio
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Riddle Memorial Hospital Cancer Center Media Pennsylvania
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Medical College of Wisconsin Cancer Center Milwaukee Wisconsin
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic - Lakeland Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Providence Cancer Center at Providence Hospital Mobile Alabama
United States Memorial Medical Center Modesto California
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Community Hospital of the Monterey Peninsula Comprehensive Cancer Center Monterey California
United States UPMC - Moon Moon Pennsylvania
United States Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown New Jersey
United States Camino Medical Group - Treatment Center Mountain View California
United States El Camino Hospital Cancer Center Mountain View California
United States Cancer Center at Ball Memorial Hospital Muncie Indiana
United States Medical Consultants, PC at Ball Memorial Cancer Center Muncie Indiana
United States Community Hospital Munster Indiana
United States Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray Utah
United States Mercy General Health Partners Muskegon Michigan
United States Edward Hospital Cancer Center Naperville Illinois
United States Hematology Oncology Consultants - Naperville Naperville Illinois
United States La Grange Oncology Associates - Geneva Naperville Illinois
United States UPMC Cancer Center - Natrona Heights Natrona Heights Pennsylvania
United States Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey
United States Jameson Memorial Hospital - North Campus New Castle Pennsylvania
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Medical Center of Louisiana - New Orleans New Orleans Louisiana
United States Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Ralph Lauren Center for Cancer Care and Prevention New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Cancer Care and Hematology Specialists of Chicagoland - Niles Niles Illinois
United States Southwest Virginia Regional Cancer Center at Wellmonth Health Norton Virginia
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Breast Surgeons, Incorporated Oakland California
United States CCOP - Bay Area Tumor Institute Oakland California
United States Highland General Hospital Oakland California
United States Kaiser Permanente Medical Center - Oakland Oakland California
United States Larry G Strieff MD Medical Corporation Oakland California
United States Tom K Lee, Incorporated Oakland California
United States Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin
United States Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden Utah
United States Cancer Care Associates - Mercy Campus Oklahoma City Oklahoma
United States Oklahoma University Cancer Institute Oklahoma City Oklahoma
United States Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields Olympia Fields Illinois
United States Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Immanuel Medical Center Omaha Nebraska
United States Methodist Estabrook Cancer Center Omaha Nebraska
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa
United States Menorah Medical Center Overland Park Kansas
United States Cancer Center of Paoli Memorial Hospital Paoli Pennsylvania
United States Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg West Virginia
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Regional Cancer Center at Singing River Hospital Pascagoula Mississippi
United States Memorial Hospital of Rhode Island Pawtucket Rhode Island
United States Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola Florida
United States West Florida Cancer Institute at West Florida Hospital - Pensacola Pensacola Florida
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania
United States Albert Einstein Cancer Center Philadelphia Pennsylvania
United States Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania
United States Frankford Hospital Cancer Center - Torresdale Campus Philadelphia Pennsylvania
United States Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania
United States Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst North Carolina
United States Mercy Cancer Institute at Mercy Hospital Pittsburgh Pennsylvania
United States St. Clair Memorial Hospital Cancer Center Pittsburgh Pennsylvania
United States UPMC - Shadyside Pittsburgh Pennsylvania
United States UPMC Cancer Center at UPMC Passavant Pittsburgh Pennsylvania
United States UPMC Cancer Center at UPMC St. Margaret Pittsburgh Pennsylvania
United States UPMC Cancer Centers Pittsburgh Pennsylvania
United States Berkshire Hematology Oncology, PC Pittsfield Massachusetts
United States Valley Care Medical Center Pleasanton California
United States Valley Medical Oncology Consultants - Pleasanton Pleasanton California
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Kaiser Permanente Health Care - Portland Portland Oregon
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Princeton Community Hospital Princeton West Virginia
United States Utah Valley Regional Medical Center - Provo Provo Utah
United States St. Mary - Corwin Regional Medical Center Pueblo Colorado
United States Kaiser Permanente Medical Center - Redwood City Redwood City California
United States Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Kaiser Permanente Medical Center - Richmond Richmond California
United States Reid Hospital & Health Care Services Richmond Indiana
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States West Suburban Center for Cancer Care River Forest Illinois
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Swedish-American Regional Cancer Center Rockford Illinois
United States Associates in Oncology and Hematology - Medical Center Drive Rockville Maryland
United States Kaiser Permanente Medical Center - Roseville Roseville California
United States William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States Kaiser Permanente Medical Center - Sacramento Sacramento California
United States South Sacramento Kaiser-Permanente Medical Center Sacramento California
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Coborn Cancer Center Saint Cloud Minnesota
United States Dixie Regional Medical Center - East Campus Saint George Utah
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States Oncology Care Associates, PLLC Saint Joseph Michigan
United States Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis Missouri
United States Christian Hospital Northeast Cancer Care Center Saint Louis Missouri
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States HealthEast Cancer Care at St. Joseph's Hospital Saint Paul Minnesota
United States Regions Hospital Cancer Care Center Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem Ohio
United States Salem Hospital Regional Cancer Care Services Salem Oregon
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute at University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah
United States Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco California
United States San Francisco General Hospital Medical Center San Francisco California
United States Kaiser Permanente Medical Center - Santa Teresa San Jose California
United States Doctors Medical Center - San Pablo Campus San Pablo California
United States Kaiser Foundation Hospital - San Rafael San Rafael California
United States North Coast Cancer Care, Incorporated Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara California
United States Kaiser Permanente Medical Center - Santa Rosa Santa Rosa California
United States Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia
United States Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah Georgia
United States Guthrie Cancer Center at Guthrie Clinic Sayre Sayre Pennsylvania
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States Hematology and Oncology Associates of Northeastern Pennsylvania Scranton Pennsylvania
United States Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Minor and James Medical, PLLC Seattle Washington
United States Polyclinic First Hill Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States Grand View Hospital Sellersville Pennsylvania
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States Shawnee Mission Medical Center Shawnee Mission Kansas
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States Hematology Oncology Associates - Skokie Skokie Illinois
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Saint Joseph Regional Medical Center South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Kaiser Permanente Medical Center - South San Francisco South San Francisco California
United States South Shore Hospital South Weymouth Massachusetts
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Mercy Medical Center Springfield Ohio
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States St. John's Regional Health Center Springfield Missouri
United States Geisinger Medical Group - Scenery Park State College Pennsylvania
United States Mount Nittany Medical Center State College Pennsylvania
United States Nalitt Cancer Institute at Staten Island University Hospital Staten Island New York
United States Kaiser Permanente Medical Facility - Stockton Stockton California
United States Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin
United States Overlook Hospital Summit New Jersey
United States Flower Hospital Cancer Center Sylvania Ohio
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Madigan Army Medical Center - Tacoma Tacoma Washington
United States Morton Hospital & Medical Center Taunton Massachusetts
United States CCOP - Scott and White Hospital Temple Texas
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States CCOP - Toledo Community Hospital Toledo Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Anne Mercy Hospital Toledo Ohio
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic, Incorporated - Main Clinic Toledo Ohio
United States Toledo Hospital Toledo Ohio
United States Cotton-O'Neil Cancer Center Topeka Kansas
United States St. Francis Comprehensive Cancer Center Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Kaiser Permanente Medical Center - Vallejo Vallejo California
United States Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland New Jersey
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Kaiser Permanente Medical Center - Walnut Creek Walnut Creek California
United States St. John Macomb Hospital Warren Michigan
United States Kent County Memorial Hospital Warwick Rhode Island
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States Washington Hospital Cancer Center Washington Pennsylvania
United States Cedar Valley Medical Specialists, PC - West Ridgeway Avenue Waterloo Iowa
United States Covenant Cancer Treatment Center Waterloo Iowa
United States Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa
United States Jennersville Regional Hospital West Grove Pennsylvania
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Cleveland Clinic Florida - Weston Weston Florida
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota
United States Clinton Memorial Hospital Wilmington Ohio
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States HealthEast Cancer Care at Woodwinds Health Campus Woodbury Minnesota
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota
United States Cancer Treatment Center Wooster Ohio
United States CCOP - Main Line Health Wynnewood Pennsylvania
United States Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania
United States Metro Health Hospital Wyoming Michigan
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 res

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From study enrollment until death from any cause; up to 3 years
Secondary 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. From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years
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