Comparison of Two preoperative treatment protocols in rectal cancer: A phase 2 study
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2024/06/068272
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method