drugset / Trial / NCT00052910
Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer
Phase 3
Completed
546 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2002-12
- Primary completion
- 2012-06
- Completion
- 2016-12
Publications
- Results 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 results from Intergroup trial CALGB 80101. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-61, 2006.
- Patel JN, Jiang C, Owzar K, Mulkey F, Luzum JA, Mamon HJ, Haller DG, Dragovich T, Alberts SR, Bjarnason G, Willet CG, Niedzwiecki D, Enzinger P, Ratain MJ, Fuchs C, McLeod HL. Pharmacogenetic study in gastric cancer patients treated with adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil before and after chemoradiation on CALGB 80101 (Alliance). Pharmacogenet Genomics. 2021 Dec 1;31(9):215-220. doi: 10.1097/FPC.0000000000000442.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | Intravenous |
| Subject | Epirubicin | Small molecule | — | Intravenous |
| Comparator | Leucovorin | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |