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Rectal NeoplasmsPhase 2SCOTCHNCT05856305

SCRT in TNT With or Without Chlorophyllin

A Phase 2 study testing Chlorophyllin, Sodium Copper Complex in people with Rectal Neoplasms, run by Tata Memorial Centre at 2 sites in India.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Rectal Neoplasms
What is being tested?
Chlorophyllin, Sodium Copper Complex
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
2 sitesIndia
Study dates
5 Jul 2023to 9 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country.

India2 sites

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

    Navi Mumbai, Maharashtra, 410210

Other trials in India

About this study

Official title: 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)

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.

Read the 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. Chlorophyllin is present in all green leaves of plants giving them green color. The drug is derived from green plant leaves. As it is a plant-based product it is safe for humans and has no known side effects of its own. 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 be compared and participants will be followed by standard protocol for 3 years.

Being tested
Chlorophyllin, Sodium Copper Complex, Placebo
Keywords
Locally Advanced rectal cancer, Sodium Copper Chlorophyllin
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorophyllin, Sodium Copper ComplexDrug

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

  • PlaceboDrug

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

Study groups in NCT05856305
Study groupRoleWhat they receive
ChlorophyllinExperimentalDrug 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
Receives: Drug: Chlorophyllin, Sodium Copper Complex
PlaceboPlacebo comparatorDrug 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months post-last cytotoxic therapy.

Secondary outcomes (9)

  1. Overall successful complete response rates

    To estimate the 3-year overall complete response rates (clinical or pathological) and complete clinical response (cCR) at 24-36 weeks post TNT in whole cohort and if any difference between chlorophyllin and control arms.

    Measured: 3 years

  2. Organ preservation rates

    To estimate the 3-year organ preservation rates, TME free survival and if any difference between chlorophyllin \& control arms.(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.)

    Measured: 3 years

  3. Disease free survival

    To estimate the 3-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.

    Measured: 3 years

  4. 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.

    Measured: 2 years

  5. 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.

    Measured: 30 days post surgery

  6. 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.

    Measured: 2 years

  7. 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.

    Measured: 2 years

  8. 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.

    Measured: 2 years

  9. To evaluate the timeline of Occurence

    To evaluate the timeline of Occurence of grade 2/3 GI toxicities (namely rectal bleeding, rectal ulcer, rectal pain, tenesmus) during SCRT based TNT.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start5 Jul 2023
  3. Primary completion9 Sep 2025
  4. Study completion9 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856305
Sponsor's protocol ID
900959
Acronym
SCOTCH
Status last verified
Sep 2026
First submitted
10 Apr 2023
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chlorophyllin, Sodium Copper Complex in people with Rectal Neoplasms, run by Tata Memorial Centre at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Toxicity (time frame: 3 months post-last cytotoxic therapy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05856305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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