Status: Closed
Activation Date: 2000MAY25
Closing Date: 2001MAY11
Phase: III
Description: A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC #616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil / Leucovorin Alone After Curative Resection for Patients with Stage III Colon Cancer
Participation: Open to member centres
Lay Description: This research is being done because patients with colon cancer who have surgery to remove their cancer are at risk for the cancer coming back. This risk can be reduced by giving chemotherapy after surgery. The purpose of this study is to determine which of the following treatment plans is more effective in preventing the return of colon cancer; a) A weekly schedule of Fluorouracil (5-FU) and Leucovorin (LV) over 32 weeks; b) A weekly schedule of Fluorouracil (5-FU) and Leucovorin (LV) plus Irinotecan (CPT-11) over 30 weeks.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | CO15 | 126 | 57 | 79 | 79 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | CO15 | 126 | 1 | 31 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | CO15 | 126 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |