Trials / Completed
CompletedNCT00174616
CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective: * Pathological complete response (ypT0N0) rate Secondary objectives: * Histopathological R0 resection rate * Pathological downstaging (ypT0-T2N0) rate * One month surgical complication rate * Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes * Safety * Local and distant recurrence rates * Progression-free survival * Overall survival
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxaliplatin, capecitabine, radiotherapy | * Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses * Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks * Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2007-11-01
- Completion
- 2007-11-01
- First posted
- 2005-09-15
- Last updated
- 2009-12-07
Locations
7 sites across 7 countries: Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00174616. Inclusion in this directory is not an endorsement.