Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Arm A: Long course chemoradiation followed by chemotherapy followed by surgery:
Radiotherapy will be planned using three dimensional conformal radiotherapy(3DCRT) or intensity modula
oxaliplatin 130 mg/m2 on day 1 and capecitabine at 1,000 g/m2 twice a day on days 1-14, repeated on a 21-day cycle ) or 9 cycles of infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX
oxaliplatin 85 mg/m2 intravenous [IV], leucovorin 400 mg/m2 IV, FU 400 mg/m2 IV push, and FU 2,400 mg/m2 over 46-48 hours by continuous infusion, repeated on a 14-day cycle). Tumor restaging will be
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Older than 18 years of age and less than 70 years 2.Clinical stage II (T3c-T4, N0) or stage III (any T, N1-2) biopsy proven rectal adenocarcinoma staged with magnetic resonance imaging (MRI), a full colonoscopy, and computed tomography (CT) of the chest, abdomen, and pelvis. 3.Eastern Cooperative Oncology Group (ECOG) score 0-1 4.Fit for Capecitabine-Oxaliplatin(CAP-OX) or FOLFOX based chemotherapy 5. Tumors located up to 10 cm from anal verge 6. Blood parameters: a white blood cell count of 4·0 × 10 ? cells per L or higher, platelet count of 100 × 10 ? per L or higher, a clinically acceptable haemoglobin level, a creatinine level indicating renal clearance of 50 mL/min or higher, and bilirubin level below 2mg/dl.
Exclusion criteria
Exclusion criteria: 1.Evidence of distant metastasis 2. Recurrent disease 3. Prior history of pelvic irradiation 4.Pelvic Kidney 5. Collagen vascular disease 6.ECOG performance status 2-3 7. Deranged kidney function tests 8.Not fit for Cap-OX or FOLFOX based chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the clinical complete response rates (cCR) defined as flat white scar or telangiectasia on colonoscopy.There will be no ulceration or nodularity on endoscopic examination. DRE (Digital rectal examination) should be normal. MRI pelvis will show thin low signal fibrosis with no evidence of intermediate signal intensity. Timepoint: 6weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the pathological complete response rates(pCR) 2. To compare the disease free survival (after 2 years from the recruitment of the last patient) 3. To compare distant metastasis free survival between the two arms(after 2 years from the recruitment of the last patient) 4.To compare local recurrences between the two arms(after 2 years from the recruitment of the last patient) 5.To compare the cumulative incidence of acute and late toxicities between the two arms. Toxicity will be reported using CTCAE V.5.0. 6. To compare compliance to surgery between the two arms Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactTapesh Bhattacharyya
Tata Medical Center,Kolkata
Outcome results
None listed