NCT05856305Active, not recruitingPhase 2
SCRT in TNT With or Without Chlorophyllin
Phase II Randomized Study of Short Course Radiotherapy Based Total Neoadjuvant Therapy & Brachytherapy Boost With Or Without Chlorophyllin In Watch And Wait Suitable Locally Advanced Rectal Cancer (SCOTCH Study)
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
The goal of this clinical trial is to see, if addition of chlorophyllin to neoadjuvant Chemo-radiotherapy can reduce the gastro-intestinal/genitourinary/hematological toxicity rates and improve the quality of life in patient's diagnosed with locally advanced rectal cancer. This is a randomized placebo control trial, wherein participants randomized to Chlorophyllin arm will receive the drug of interest along with the standard treatment. Participants randomized to other arm will receive placebo along with the standard treatment. Researchers will compare the difference between the outcomes from both the arms and will also observe the non-operative management success rates.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 10 Apr 2023
- Start date
- 5 Jul 2023
- Primary completion date
- 9 Sept 2025
- Lead sponsor
- Tata Memorial Centre
- Diseases
- Colorectal cancer
- NCT number
- NCT05856305
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 76
- From 5 Jul 2023 to the primary completion date, 9 Sept 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recurrent rectal cancer or previous pelvic radiotherapy
- 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 investigator's judgment, would make them inappropriate candidates for entry into this study.
Other illness
- Signet or mucinous histology cancer of rectum
- Primary unresectable rectal 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.
- Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
Lab values
- Creatinine level greater than 1.5 times the upper limit of normal.
Other
- Patients who are unable to undergo an MRI.
- Poor reliability for follow up.
- Ineligible as per eligibility criteria
Who the study is looking for
- Age \> 18 years.
- Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- Clinical Stage II/III (T2-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0-2) based on MRI.
- Non-circumferential tumours with craniocaudal length \<7 cm
- The tumours of the lower rectum, or starting up to 7 cm from the anal verge.
- No evidence of distant metastases on CT Chest and Abdomen.
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
- Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team.
- Absolute neutrophil count (ANC) \> 1.5 cells/mm3, hemoglobin (HGB) \> 8.0 gm/dl, platelet (PLT) \> 150,000/mm3.
- Total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), aspartate aminotransferase (AST) ≤ 3 x ULN, alanine transaminase (ALT) ≤ 3 x ULN.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Coordinator of this site? Confirm its status | Navi Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.