Health Condition 1: C20- Malignant neoplasm of rectum Health Condition 2: O- Medical and Surgical Health Condition 3: D- Radiation Therapy
Conditions
Interventions
Intervention1: chemotherapy, radiation and surgery: � CRT group treatment protocol: All the patients in CRT group would receive neoadjuvant long course chemoradiation with capecitabine (CAP) 825
Sponsors
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
Eligibility
Inclusion criteria
Inclusion criteria: 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 ââ?°Â¤ 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ 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
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Disease free survival (DFS) and overall survival (OS) ââ?¬Â¢ Effect of neoadjuvant treatment: Efficacy and safety, tolerability and toxicity, compliance and Completion of scheduled treatment ââ?¬Â¢ Radiological response before Surgery ââ?¬Â¢ Perioperative complications ââ?¬Â¢ Stoma reversal rate at 3 months post-surgery Timepoint: post 3 years of completion of recruitment and treatment of last patient. | — |
Countries
India
Contacts
Public ContactCharan Singh
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
Outcome results
None listed