Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Chemoradiotherapy followed by Capecitabine and oxaliplatin: Three cycles of Capecitabine and Oxaliplatin will be administered 2 weeks after completion of neoadjuvant chemoradiotherapy (
Sponsors
Medical College Kolkata
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically and radiologically stage T3 and T4 rectal carcinoma. 2. Any T stage with lymph node positive on imaging. 3. Tumour located within 12cm of anal verge. 4. ECOG performance scale 0-2
Exclusion criteria
Exclusion criteria: 1. Metastatic disease 2. History of previous pelvic irradiation or chemotherapy for rectal carcinoma. 3. Synchronous malignancy. 4. Associated colonic polyposis. 5. Obvious or suspected intestinal obstruction (eligible if proximal diversion stoma relieved the obstruction). 6. Any serious medical comorbid condition that precludes systemic therapy. 7. Previously treated for other malignancy except for non-melanoma skin cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate of pathological complete response in both arm.Timepoint: During the histopathological examination specimen of definitive surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Chemotoxicity due to added consolidation chemotherapyTimepoint: After completion of chemotherapy;Overall survival and recurrence free survivalTimepoint: After 1 year of definitive surgery;Radiological response of tumour to neoadjuvant therapyTimepoint: 12 weeks after completion of chemoradiotherapy in comparative arm and 4 weeks after completion of chemotherapy in intervention arm | — |
Countries
India
Contacts
Public ContactDr Ravi Shankar Biswas
Medical College, Kolkata
Outcome results
None listed