CTRI/2023/04/051458
Recruiting
Phase 2
Short course radiotherapy based total neoadjuvent therapy with or without chlorophyllin - SCOTCH study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Sponsor
- Tata Memorial Hospital
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \> 18 years.
- •2\.Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- •3\.Clinical Stage II/III (T2\-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0\-2\) based on MRI.
- •4\.Non\-circumferential tumours with craniocaudal length \<7 cm
- •5\.The tumours of the lower rectum, or starting up to 7 cm from the anal verge.
- •6\.No evidence of distant metastases on CT Chest and Abdomen.
- •7\.No prior pelvic radiation therapy
- •8\.No prior chemotherapy or surgery for rectal cancer
- •9\.ECOG Performance status 0\-2
- •10\.Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Exclusion Criteria
- •\-Signet or mucinous histology cancer of rectum
- •\-Recurrent rectal cancer or previous pelvic radiotherapy
- •\-Primary unresectable 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 any arterial thrombotic event within the past 6 months. This includes angina stable or unstable, MI, TIA, or CVA.
- •\-Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
- •\-Patients with a history of venous thrombotic episodes such as deep venous thrombosis, and pulmonary embolism occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for a trial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
- •\-Patients with any other concurrent medical or psychiatric condition or disease which, in the investigators judgment would make them inappropriate candidates for entry into this study.
- •\-Poor reliability for follow up.
Outcomes
Primary Outcomes
Not specified
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