CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
Phase 2
Completed
- Conditions
- Rectal Neoplasms
- Interventions
- Drug: Oxaliplatin, capecitabine, radiotherapy
- Registration Number
- NCT00174616
- Lead Sponsor
- Sanofi
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Oxaliplatin, capecitabine, radiotherapy -
- Primary Outcome Measures
Name Time Method MRI staging and TME surgery within 4 - 6 weeks after completion XELOX-RT
- Secondary Outcome Measures
Name Time Method Measure safety - NCI-CTC version 2 from baseline to end of study
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇬🇧Guildford Surrey, United Kingdom