SCRT in TNT With or Without Chlorophyllin

NCT05856305 | Active Not Recruiting Phase 2

• 1 other identifier: 900959
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Neoplasms

Keywords

Locally Advanced rectal cancer; Sodium Copper Chlorophyllin

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity

  Incidence of grade 2 or higher Common Terminology Criteria for Adverse Events (CTCAE) acute gastro-intestinal (GI)/genitourinary (GI)/haematological toxicity (HT) in advanced rectal cancer. Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 late toxicity means a good outcome. Grade 2 or higher late toxicity means a worse outcome.

  3 months post-last cytotoxic therapy.

Secondary Outcomes (9)

• Overall successful complete response rates

  3 years

• Organ preservation rates

  3 years

• Disease free survival

  3 years

• Treatment related early and late toxicities

  2 years

• Estimation of surgical complications

  30 days post surgery

Study Arms (2)

Chlorophyllin

EXPERIMENTAL

Drug name: Sodium Copper Chlorophyllin Dosage form: Tablet Dosage: 750 mg Route of administration: Oral Frequency: Once daily in the morning before food. Duration: From 10-14 days before radiotherapy up to 3 months after the last dose of cytotoxic therapy

Drug: Chlorophyllin, Sodium Copper Complex

Placebo

PLACEBO COMPARATOR

Drug Name: Placebo Dosage form: 1 Tablet Route of administration: Oral Frequency: Once daily in the morning before food. Duration: From 10-14 days before radiotherapy up to 3 months after the last dose of cytotoxic therapy

Drug: Placebo

Interventions

Chlorophyllin, Sodium Copper Complex DRUG

Additional Chlorophyllin tablet with Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose

Chlorophyllin

Placebo DRUG

Additional Placebo tablet with Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 investigator's judgment, would make them inappropriate candidates for entry into this study.
• Poor reliability for follow up.
• Ineligible as per eligibility criteria

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

chlorophyllin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Prof. Rahul Krishnatry, M.D.

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 12, 2023
• Study Start: July 5, 2023
• Primary Completion: September 9, 2025
• Study Completion (Estimated): September 9, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)