SCRT in TNT with or without chlorophylli

Phase 2

Conditions: Health Condition 1: C20- Malignant neoplasm of rectum

Registration Number: CTRI/2023/04/051458

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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.

11.Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team.

11.1. ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3.

11.2. Total bilirubin <= 1.5 x ULN (except in patients with Gilbertâ??s Syndrome who must have total bilirubin <= 3.0 x ULN), AST<= 3 x ULN, ALT <= 3 x ULN.

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.

-Ineligible as per eligibility criteria