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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) North Central Cancer Treatment Group Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052910 |
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.
Condition | Intervention | Phase |
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Esophageal Cancer Gastric Cancer |
Drug: cisplatin Drug: epirubicin hydrochloride Drug: fluorouracil Drug: leucovorin calcium Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma |
Estimated Enrollment: | 824 |
Study Start Date: | December 2002 |
Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
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.
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Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Radiation: radiation therapy
Given 5 days a week for 5 weeks
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Arm II: Experimental
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 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. |
Drug: cisplatin
Given IV
Drug: epirubicin hydrochloride
Given IV
Drug: fluorouracil
Given IV
Radiation: radiation therapy
Given 5 days a week for 5 weeks
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OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (adenocarcinoma of the esophagus must involve the gastroesophageal junction) meeting the following criteria:
Prior en bloc resection, with curative intent, of all known tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except the following:
Radiotherapy
Surgery
Study Chair: | Charles S. Fuchs, MD | Dana-Farber Cancer Institute |
Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
Study Chair: | Daniel G. Haller, MD | University of Pennsylvania |
Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
Study ID Numbers: | CDR0000258787, CALGB-80101, NCCTG-CALGB-80101, ECOG-CALGB-80101 |
Study First Received: | January 24, 2003 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00052910 History of Changes |
Health Authority: | Unspecified |
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 |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Leucovorin Anti-Bacterial Agents Stomach Diseases Cisplatin Vitamins Stomach Neoplasms Micronutrients Vitamin B Complex Digestive System Neoplasms Adjuvants, Immunologic Trace Elements |
Esophageal Cancer Epirubicin Immunosuppressive Agents Carcinoma Calcium, Dietary Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Leucovorin Antibiotics, Antineoplastic Neoplasms by Site Stomach Diseases Vitamins Stomach Neoplasms Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Immunosuppressive Agents Epirubicin Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases |