Comparison between 5 days of radiotherapy followed by chemotherapy with 25 days of radiotherapy with daily oral chemotherapy in locally advance rectal cancer
Phase 2
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2023/10/058369
- Lead Sponsor
- AIl India institute of medical sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Ecog ps > 1, previously untreated biopsy proven rectal adenocarcinoma, locally advanced tumor fulfilling at least one of the following criteria on pelvic mri/cect_ct3-t4, node positive, mesorectal fascia involvement, metastatic lateral lymph node, extra mural vascular invasion, adequate blood counts, adequate renal function, adequate hepatic functions.
Exclusion Criteria
a.Evidence of recurrence /distant metastasis(M1).
b. Patient who received prior treatment for rectal cancer.
c. Concurrent uncontrolled medical condition.
d. Pregnant/breast feeding.
e. Active Crohn’s disease or ulcerative colitis.
f. Synchronous malignancies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the clinical, radiological and metabolic response rates between of patients receiving Short Course Radiotherapy (SCRT) followed by chemotherapy and conventional long course CRT.Timepoint: Week 12-13 of treatment.
- Secondary Outcome Measures
Name Time Method To compare the rates of pathological complete response between groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. <br/ ><br>To assess the Disease-Free Survival between groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. <br/ ><br>To compare the rates of radiation toxicities in groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. <br/ ><br>To compare the rates of post-operative complications in groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. <br/ ><br>Timepoint: 1.5YEARS