comparison between short course radiotherapy and long course radiotherapy in Rectal cancer
Phase 2
- Conditions
- Health Condition 1: null- Carcinoma RectumHealth Condition 2: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2018/05/013917
- Lead Sponsor
- Shashank Bansal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age >= 18 years and < 70 years
ECOG performance score <= 1
Written informed consent
Biopsy proven rectal adenocarcinoma
Metastatic lateral lymphnodes (LN+)
Involved mesorectal fascia (MRF+)
Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI:
cT2 ,cT3,cT4a
cN1, cN2
Creatinine levels indicating renal clearance >= 50 ml/min
Bilirubin < 35 μmol/L
Exclusion Criteria
Tumour involving lumbosacral nerve roots
Tumor T4b
Distant metastasis (M1)
Recurrent rectal cancer
FAP or HNPCC, Active Chrons disease
Contraindications to MRI (e.g. pacemaker)
Myocardial infarction within past 12 months or clinically significant cardiac disease
Inability to give informed consent
Concomitant malignancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological Complete ResponseTimepoint: 12-14 week
- Secondary Outcome Measures
Name Time Method Radiology ResponseTimepoint: 11 week