Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Dose escalated neoadjuvant radiotherapy in locally advanced carcinoma rectum with simultaneous integrated boost (SIB): 25Gy in 5 fractions @5 Gy per fraction over 5 weeks to the whole p
Sponsors
Chittaranjan National Cancer Institute (CNCI)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years and 2. Biopsy proven locally advanced adenocarcinoma of rectum 3. ECOG PS 0-2 4. Colonoscopy with tumour 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 7. Physically and mentally fit for the treatment and follow up
Exclusion criteria
Exclusion criteria: 1. ECOG PS 3-4 2. Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the acute and chronic toxicities with the dose escalated protocolTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the pathological complete response rates with the new protocol. Timepoint: 5 months;2. To assess the recurrence rate (locoregional and distal metastases)Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDR SAYAN KUNDU
Chittaranjan National Cancer Institute (CNCI)
Outcome results
None listed