drugset / Trial / NCT01060501
Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer
Phase 3
Completed
796 enrolled
University of Ulm
Medac, Hamburg, Germany · collabRoche (Grenzach-Wyhlen, Germany) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or INF-alpha may increase overall survival.
Timeline
- Start
- 1992-07
- Primary completion
- 2009-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 6e+06 iu | Subcutaneous |
| Background | fluorouracil | Small molecule | 450 mg/m2 | Intravenous |