A single center study to assess the safety and efficacy of escalated dose radiotherapy in locally advanced carcinoma rectum
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2023/10/059088
- Lead Sponsor
- Chittaranjan National Cancer Institute (CNCI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age >18 years and <75 years
2. Biopsy proven locally advanced adenocarcinoma of rectum
3. ECOG PS 0-2
4. Colonoscopy with tumour <16cm from anal verge
5. Pelvic MRI with atleast one of the high risk features e.g. high tumour stage (cT4a or cT4b) and/ or high nodal stage (cN2 or more) and/ or extramural vascular invasion and/ or involved mesorectal fascia by tumour or lymph node
6. Acceptable laboratory parameters with hemoglobin level > 8.5 gm%, white blood cell count > 4000/cc, platelet count > 1,00,000/ cc, creatinine clearance > 50ml/min and bilirubin level <2 mg%
7. Physically and mentally fit for the treatment and follow up
1. ECOG PS 3-4
2. Age <18 years or > 75 years
3. Extensive growth of the rectal tumour into the cranial part of the sacrum or the lumbosacral nerve roots indicating that surgery will never be possibleeven if substantial tumour downsizing is seen and presence of metastatic disease or recurrent rectal cancer.
4. Any prior treatment for cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the acute and chronic toxicities with the dose escalated protocolTimepoint: 2 years
- Secondary Outcome Measures
Name Time Method 1. To evaluate the pathological complete response rates with the new protocol. <br/ ><br>Timepoint: 5 months;2. To assess the recurrence rate (locoregional and distal metastases)Timepoint: 2 years