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Study 18 of 4397 for search of: | United States, Georgia |
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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 Procedure: 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
Procedure: 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.
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Drug: cisplatin
Given IV
Drug: epirubicin hydrochloride
Given IV
Drug: fluorouracil
Given IV
Procedure: 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.
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 |
Study ID Numbers: | CDR0000258787, CALGB-80101, NCCTG-CALGB-80101, ECOG-CALGB-80101 |
Study First Received: | January 24, 2003 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00052910 |
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 |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Leucovorin Stomach cancer Epirubicin Carcinoma Calcium, Dietary Digestive System Diseases |
Stomach Diseases Cisplatin Fluorouracil Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Vitamin B Complex Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |