drugset / Trial / NCT00422864
A Single Arm Trial of Oxaliplatin and 5FU With Concurrent Radiation in Patients With Metastatic Rectal Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This trial is a single-arm study for patients presenting with both local and metastatic adenocarcinoma of rectum. The aims of the trial are (1) to determine the tolerability rate, and (2) to determine toxicity rates, pelvic and distant response rates in patients with locally advanced rectal cancer in the presence of distant metastasis who are treated with an interdigitating chemotherapy (oxaliplatin/5-fluorouracil \[5FU\]) and radiotherapy regimen.
Timeline
- Start
- 2006-10
- Primary completion
- 2009-06
- Completion
- 2011-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 200 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2.4 g | — |
| Background | Leucovorin | Small molecule | 200 mg/m2 | — |