Rectal Neoplasms
Conditions
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
Interventions
* 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
Sponsors
Study design
Eligibility
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI staging and TME surgery | within 4 - 6 weeks after completion XELOX-RT |
Secondary
| Measure | Time frame |
|---|---|
| Measure safety - NCI-CTC version 2 | from baseline to end of study |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom