Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Chorophyllin: Sodium-copper-chlorophyllin (CHL) is a phytopharmaceutical drug obtained from the green plant pigment, chlorophyll. It is a semi-synthetic mixture of sodium copper salts d
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 2 or higher acute GI/GU/haematological toxicityTimepoint: 3 months post-last cytotoxic therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the 2-year overall complete response rates (clinical or pathological) in whole cohort and if any difference between chlorophyllin and control arms.Timepoint: 2 years;To estimate the 2-year organ preservation rates, TME free survival and if any difference between chlorophyllin and control arms.Timepoint: 2 years;To estimate the 2-year disease free survival, Distant metastasis free survival, loco-regional failure free survival, and overall survival rates in the whole cohort, and if any difference between two arms and between patients with successful NOM versus others.Timepoint: 2 years;To compare treatment-related early and late toxicities (grade 2 CTCAE v5) for two years between the groups as (3).Timepoint: 2 years;To estimate surgical complications based on Clavien-Dindo classificationTimepoint: 30 days post surgery;To estimate and compare Health Related Quality Of Life (EORTC QOL-C30, CR 29, PRT 20, SH 22), and LARS, IPSS scores between various groups as (3).Timepoint: 2 years;To estimate direct cost benefit with reduction in toxicityTimepoint: 2 years;To study the tumour volume reduction kinetics and radiotherapy doses and probability of successful NOM outcomes.Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Rahul Krishnatry
Tata Memorial Hospital
Outcome results
None listed