Trials / Completed
CompletedNCT00263029
Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer
Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxaliplatin | 60mg/m² as a 2-hour intravenous infusion every week for 5-6 week |
| DRUG | Capecitabine | 500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart |
| RADIATION | Radiotherapy | Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions |
Timeline
- Start date
- 2002-06-01
- Primary completion
- 2007-03-01
- First posted
- 2005-12-07
- Last updated
- 2009-09-18
Source: ClinicalTrials.gov record NCT00263029. Inclusion in this directory is not an endorsement.