Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Dose escalated radiotherapy: All patients will receive neoadjuvant chemoradiotherapy. Radiotherapy to the pelvis will be delivered by 3DCRT or IMRT technique to a dose of 45-50Gy/25#/5w
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: -Clinical Stage T2-T3 -Histologically confirmed diagnosis of adenocarcinoma of the rectum -The distance from anal verge of tumor upto 10 cm(Mid and low rectal tumors) -Palpable upper limit -Involving less than 2/3rd of the circumference -ECOG Performance status 0-1
Exclusion criteria
Exclusion criteria: -Recurrent rectal cancer -Having pathology of signet ring cell carcinoma -Evidence of distant metastases -Prior pelvic radiotherapy, chemotherapy or surgery for rectal cancer -Creatinine level greater than 1.5 times the upper limit of normal. -Patients who are unable to undergo an MRI. -Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer. -Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA. -Other Anticancer or Experimental Therapy. -Women who are pregnant or breast-feeding. -Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study. -Not willing to consent for the study -Unreliable for close follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete or near complete clinical response rate of the primary rectal tumors at 12 weeks.Timepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Organ Preservation Rate -Rate of local regrowth -Rate of disease-free and overall survival -Rate of patients without stoma at 2 years -Morbidity after chemoradiotherapy and brachytherapy related toxicity (assessed by CTCAE scoring V 5- acute within 3 months after treatment, late at 6 months, then 3 monthly Surgical morbidity -Quality of life assessment Timepoint: 24 months | — |
Countries
India
Contacts
Public ContactReena Engineer
Tata Memorial Hospital
Outcome results
None listed