CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Capecitabine; Oxaliplatin

Criteria

• 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.