|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) North Central Cancer Treatment Group Eastern Cooperative Oncology Group |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00052910 |
Purpose
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 |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: cisplatin Drug: epirubicin hydrochloride Drug: fluorouracil Drug: leucovorin calcium Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma |
| Enrollment: | 546 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
|
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Radiation: radiation therapy
Given 5 days a week for 5 weeks
|
|
Experimental: 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 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
|
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.
Eligibility| 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
Contacts and Locations
Show 535 Study Locations| Study Chair: | Charles S. Fuchs, MD | Dana-Farber Cancer Institute |
| Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
| Study Chair: | Daniel G. Haller, MD | Abramson Cancer Center of the University of Pennsylvania |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00052910 History of Changes |
| Other Study ID Numbers: | CDR0000258787, U10CA031946, CALGB-80101, NCCTG-CALGB-80101, ECOG-CALGB-80101 |
| Study First Received: | January 24, 2003 |
| Last Updated: | April 8, 2011 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Adenocarcinoma Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Stomach Diseases |
Cisplatin Epirubicin Fluorouracil Leucovorin Levoleucovorin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents |