A Randomized Study Comparing complete Chemo-radiotherapy Before Surgery Versus Conventional Preoperative Chemo-radiotherapy Followed by Surgery and Chemotherapy in Locally Advanced Rectal Cancer
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectumHealth Condition 2: O- Medical and SurgicalHealth Condition 3: D- Radiation Therapy
- Registration Number
- CTRI/2022/09/045291
- Lead Sponsor
- KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age between 18 to 75 years
2. Newly diagnosed locally advanced primary resectable rectal adenocarcinoma on biopsy without distant metastases
3. Lower border of tumour � 15 cm from Anal Verge
4. High risk features on MRI: any one of below
T3 anyN M0, T4 any N M0, anyT N1+ M0, Threatened CRM, MRF involvement, Extramural vascular invasion
5. Eastern Cooperative Oncology Group (ECOG) performance score of 0ââ?¬â??2
6. Written informed consent
1. Extensive tumor growth leading to primarily unresectable eg. Tumor involving lumbosacral nerve root, tumor involving lateral pelvic wall, tumor involving sacrum S3 and above
2. Recurrent rectal cancer
3. Partially treated patients
4. FAP or HNPCC, Active Crohnââ?¬•s disease or ulcerative colitis
5. Concomitant malignancy
6. History of peripheral neuropathy
7. History of Cardiac disease / Stroke
8. Chronic kidney disease
9. Chronic liver disease with bilirubin more than 2 mg/dl
10. Pregnant or breast-feeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method �Pathological response in resected specimen: pCR, R0, R1Timepoint: post recruitment of study patients with completion of treatment, all patients will analyzed for primary outcome.
- Secondary Outcome Measures
Name Time Method �Disease free survival (DFS) and overall survival (OS) <br/ ><br>�Effect of neoadjuvant treatment: Efficacy and safety, tolerability and toxicity, compliance and Completion of scheduled treatment <br/ ><br>�Radiological response before Surgery <br/ ><br>�Perioperative complications <br/ ><br>�Stoma reversal rate at 3 months post-surgery <br/ ><br>Timepoint: post 3 years of completion of recruitment and treatment of last patient.