Outcome of patient receiving additional chemotherapy after chemoradiotherapy for locally advanced rectal carcinoma compared to those receiving only chemoradiotherapy
Phase 3
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2021/05/033642
- Lead Sponsor
- Medical College Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Clinically and radiologically stage T3 and T4 rectal carcinoma.
2. Any T stage with lymph node positive on imaging.
3. Tumour located within 12cm of anal verge.
4. ECOG performance scale 0-2
Exclusion Criteria
1. Metastatic disease
2. History of previous pelvic irradiation or
chemotherapy for rectal carcinoma.
3. Synchronous malignancy.
4. Associated colonic polyposis.
5. Obvious or suspected intestinal obstruction
(eligible if proximal diversion stoma
relieved the obstruction).
6. Any serious medical comorbid condition that
precludes systemic therapy.
7. Previously treated for other malignancy
except for non-melanoma skin cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the rate of pathological complete response in both arm.Timepoint: During the histopathological examination specimen of definitive surgery.
- Secondary Outcome Measures
Name Time Method Chemotoxicity due to added consolidation chemotherapyTimepoint: After completion of chemotherapy;Overall survival and recurrence free survivalTimepoint: After 1 year of definitive surgery;Radiological response of tumour to neoadjuvant therapyTimepoint: 12 weeks after completion of chemoradiotherapy in comparative arm and 4 weeks after completion of chemotherapy in intervention arm