Health Condition 1: C20- Malignant neoplasm of rectum Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Neoadjuvant FOLFIRINOX: chemotherapy regimen involves administering Oxaliplatin at a dosage of 85 mg/m² as a 2-hour infusion on day 1 of a 2-week cycle, repeated for 6 cycles. On the sa
Sponsors
AIIMS, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. Newly diagnosed rectal cancer. 3. Histologically proven rectal adenocarcinoma. 4. Tumour location: mid and lower rectum 5. ECOG (Eastern cooperative oncology group) performance status 0 and 1) 6. cT3, cT4 and N+/- as per AJCC 8th TNM classification 7. Threatened CRM
Exclusion criteria
Exclusion criteria: 1. Gross tumour infiltration into sacrum and lumbosacral nerve roots. 2. Distant metastasis. 3. Weight loss more than 20% in last 2 months. 4. History of treatment for previous malignancy. 5. Pregnant or lactating women. 6. Immunocompromised patients. 7. Patient refused for consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of chemotherapy to neoadjuvant long course chemo radiotherapy in terms of complete pathological response.Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the toxicity profile of chemotherapy and neoadjuvant long course chemo radiotherapy. 2. Sphincter preservationTimepoint: 18 months | — |
Countries
India
Contacts
Public ContactRao Bhupender Yadav
AIIMS, New Delhi
Outcome results
None listed