Back to resultsSCRT in TNT With or Without Chlorophyllin (SCOTCH)
Primary Purpose
Rectal Neoplasms
Status
Recruiting
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Chlorophyllin, Sodium Copper Complex
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasms focused on measuring Locally Advanced rectal cancer, Sodium Copper Chlorophyllin
Eligibility Criteria
Inclusion Criteria: 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. 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 investigator's judgment, would make them inappropriate candidates for entry into this study. Poor reliability for follow up. Ineligible as per eligibility criteria
Sites / Locations
- Tata Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Chlorophyllin
Placebo
Arm Description
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 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
Outcomes
Primary Outcome Measures
Acute Toxicity
Incidence of grade 2 or higher Common Terminology Criteria for Adverse Events (CTCAE) acute gastro-intestinal (GI)/genitourinary (GI)/haematological toxicity (HT).
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.
Secondary Outcome Measures
Overall successful complete response rates
To estimate the 2-year overall complete response rates (clinical or pathological) in whole cohort and if any difference between chlorophyllin and control arms.
Organ preservation rates
To estimate the 2-year organ preservation rates by estimating patients who did not need surgery for rectal cancer (Total mesorectal excision; TME) at two years and if any difference between chlorophyllin and control arms.
Disease free survival
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 non-operative management versus others.
Treatment related early and late toxicities
To compare treatment-related early and late toxicities (grade 2 Common Terminology Criteria for Adverse Events, version 5.0) for two years between the groups as (3).
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.
Estimation of surgical complications
To estimate surgical complications based on Clavien-Dindo classification. Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 surgical complications means a good outcome. Grade 2 or higher surgical complications means a worse outcome.
Health related quality of life
To estimate and compare Health Related Quality of Life (QOL) between various groups as (3). using quality of life questionnaires (QLQ) of European Organization for Research and Treatment of Cancer (EORTC) These questionnaires will be filled by patient at six month interval of follow up.
Cost benefit with reduction in toxicity
The direct cost of per patient for various supportive medications, hospital admissions will be estimated in both arms and compared to see if any financial benefit of reduction in toxicity.
Record of medicines and details of hospitalization will be maintained.
Tumor Volume reduction kinetics
To study the correlation of tumour volume with used radiotherapy doses leading to a successful non-operative management versus not in the study group of patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05856305
Brief Title
SCRT in TNT With or Without Chlorophyllin
Acronym
SCOTCH
Official Title
Short Course Radiotherapy Based Total Neoadjuvant Therapy With or Without Chlorophyllin (SCOTCH Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tata Memorial Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The current standard treatment for locally advanced rectal cancer includes neoadjuvant (treatment given before Surgery) radiotherapy & chemotherapy followed by surgery if needed or wait and watch in patients whom tumour has completely regressed. It has been observed that even after receiving this intensive treatment patients, almost 70% of patients develop acute toxicity (during or within 3 months) of grade 2 or higher (needing medication for toxicity). This affects their treatment tolerance, completion and quality of life.
In this study Researchers are going to see if addition of drug Chlorophyllin (derived from green plant leaves) along with standard treatment would help in reducing the acute toxicity. This is a randomized study which has two arms; Arm 1 is test arm where participants will receive drug of interest (Chlorophyllin) and in other arm participants will receive Placebo. Upon successful completion of study, outcomes from both the study arm will compared and participants will be followed by standard protocol for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Locally Advanced rectal cancer, Sodium Copper Chlorophyllin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chlorophyllin
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Chlorophyllin, Sodium Copper Complex
Intervention Description
Additional Chlorophyllin tablet with Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Additional Placebo tablet with Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose
Primary Outcome Measure Information:
Title
Acute Toxicity
Description
Incidence of grade 2 or higher Common Terminology Criteria for Adverse Events (CTCAE) acute gastro-intestinal (GI)/genitourinary (GI)/haematological toxicity (HT).
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.
Time Frame
3 months post-last cytotoxic therapy.
Secondary Outcome Measure Information:
Title
Overall successful complete response rates
Description
To estimate the 2-year overall complete response rates (clinical or pathological) in whole cohort and if any difference between chlorophyllin and control arms.
Time Frame
2 years
Title
Organ preservation rates
Description
To estimate the 2-year organ preservation rates by estimating patients who did not need surgery for rectal cancer (Total mesorectal excision; TME) at two years and if any difference between chlorophyllin and control arms.
Time Frame
2 years
Title
Disease free survival
Description
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 non-operative management versus others.
Time Frame
2 years
Title
Treatment related early and late toxicities
Description
To compare treatment-related early and late toxicities (grade 2 Common Terminology Criteria for Adverse Events, version 5.0) for two years between the groups as (3).
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.
Time Frame
2 years
Title
Estimation of surgical complications
Description
To estimate surgical complications based on Clavien-Dindo classification. Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 surgical complications means a good outcome. Grade 2 or higher surgical complications means a worse outcome.
Time Frame
30 days post surgery
Title
Health related quality of life
Description
To estimate and compare Health Related Quality of Life (QOL) between various groups as (3). using quality of life questionnaires (QLQ) of European Organization for Research and Treatment of Cancer (EORTC) These questionnaires will be filled by patient at six month interval of follow up.
Time Frame
2 years
Title
Cost benefit with reduction in toxicity
Description
The direct cost of per patient for various supportive medications, hospital admissions will be estimated in both arms and compared to see if any financial benefit of reduction in toxicity.
Record of medicines and details of hospitalization will be maintained.
Time Frame
2 years
Title
Tumor Volume reduction kinetics
Description
To study the correlation of tumour volume with used radiotherapy doses leading to a successful non-operative management versus not in the study group of patients.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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 investigator's judgment, would make them inappropriate candidates for entry into this study.
Poor reliability for follow up.
Ineligible as per eligibility criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Rahul Krishnatry, M.D.
Phone
022-24177000
Ext
7028
Email
krishnatry@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Rahul Krishnatry, M.D.
Organizational Affiliation
Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahul Krishnatry, MD
Phone
022-24177000
Ext
7028
Email
krishnatry@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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SCRT in TNT With or Without Chlorophyllin
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