Status:
COMPLETED
CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
Lead Sponsor:
Sanofi
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective: * Pathological complete response (ypT0N0) rate Secondary objectives: * Histopathological R0 resection rate * Pathological downstaging (ypT0-T2N0) rate * One month surgical compli...
Eligibility Criteria
Inclusion
- Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge)
- No evidence of distant spread
- No prior therapy for chemotherapy or radiation therapy for rectal cancer
- Patient considered locally advanced by MRI:
- Tumour beyond mesorectal fascia, or
- Tumour ≤ 2mm from mesorectal fascia, or
- T3 tumour \< 5cm from anal verge
- For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
- No peripheral neuropathy \> grade1
- ECOG PS ≤ 2
- ANC \> 1,500 x 10\^9/L
- Platelets \> 100,000 x 10\^9/L
- Creatinine \< 1.5 x IULN
- Bilirubin \< 1.5 IULN
- SGPT (ALT) \< 2.5 IULN
- No pre-existing condition which would deter chemoradiotherapy
- No uncontrolled diarrhoea or fecal incontinence
- No significant small bowel (\> 200cc or 6X6X6cm) delineated within the radiation fields
- No other serious uncontrolled concomitant illness
- Informed consent signed
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00174616
Start Date
July 1 2003
End Date
November 1 2007
Last Update
December 7 2009
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Diegem, Belgium
2
Sanofi-Aventis Administrative Office
Paris, France
3
Sanofi-Aventis Administrative Office
Frankfurt, Germany
4
Sanofi-Aventis Administrative Office
Milan, Italy