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Tracking Information | |||||||||||||
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First Received Date † | January 24, 2003 | ||||||||||||
Last Updated Date | May 8, 2009 | ||||||||||||
Start Date † | December 2002 | ||||||||||||
Current Primary Outcome Measures † |
Overall survival [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00052910 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † | |||||||||||||
Original Secondary Outcome Measures † | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer | ||||||||||||
Official Title † | Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma | ||||||||||||
Brief 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. |
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Detailed Description | 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. |
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Study Phase | Phase III | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Active Control | ||||||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Recruiting | ||||||||||||
Enrollment † | 824 | ||||||||||||
Completion Date | |||||||||||||
Estimated Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States, Canada | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00052910 | ||||||||||||
Responsible Party | Richard L. Schilsky, Cancer and Leukemia Group B | ||||||||||||
Secondary IDs †† | CALGB-80101, NCCTG-CALGB-80101, ECOG-CALGB-80101 | ||||||||||||
Study Sponsor † | Cancer and Leukemia Group B | ||||||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | May 2009 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |