drugset / Trial / NCT01212718
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
Phase 2
Completed
168 enrolled
University of Ulm
Medac, Hamburg, Germany · collabPfizer, Berlin Germany · collabStudy Group Oncology of Gastrointestinal Tumors (FOGT) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC.
Timeline
- Start
- 2001-07
- Primary completion
- 2010-06
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-flurouracil | Unknown | 2000 mg/m2 | Intravenous |
| Subject | 5-flurouracil | Unknown | 2600 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 500 mg/m2 | Intravenous |