| CTRI Number |
CTRI/2022/02/040331 [Registered on: 15/02/2022] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To test effect of hydrogen peroxide on radiation sensitivity in breast cancer patients |
|
Scientific Title of Study
|
Randomised phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced or recurrent breast cancer |
| Trial Acronym |
KORTUC Phase II |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2019-001709-25 |
EudraCT |
| 264012 |
Other |
| CCR5119 Version 4 dated 22 Jan 2023 |
Protocol Number |
| NCT 03946202 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Snr. Consultant Clinical Oncologist (MRCP, FRCP, FRCR) |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center, 14 MAR (E-W), DH Block (Newtown), Action Area I, Newtown
Kolkata
WEST BENGAL
700160
India |
| Phone |
913366057000 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Snr. Consultant Clinical Oncologist (MRCP, FRCP, FRCR) |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center, 14 MAR (E-W), DH Block (Newtown), Action Area I, Newtown
Kolkata
WEST BENGAL
700160
India |
| Phone |
913366057000 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Snr. Consultant Clinical Oncologist (MRCP, FRCP, FRCR) |
| Affiliation |
Tata Medical Center |
| Address |
Tata Medical Center, 14 MAR (E-W), DH Block (Newtown), Action Area I, Newtown
Kolkata
WEST BENGAL
700160
India |
| Phone |
913366057000 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
| CRUK Convergence Science Centre – Development Fund, UK |
| Kortuc Inc. Japan
|
| UK Research and Innovation – Global Challenges Research Fund, UK |
|
|
Primary Sponsor
|
| Name |
The Institute of Cancer Research |
| Address |
123 Old Brompton Road, London SW7 3RP, UK |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDS INDIA PRIVATE LIMITED |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103
Contact Number: 995 888 1837
Email address: sneha.gupta2@iqvia.com |
|
|
Countries of Recruitment
|
India
United Kingdom |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Selvamani Backianathan |
Christian Medical College |
Department of Radiation Oncology Unit III, Vellore – 632004, Tamilnadu
Vellore
TAMIL NADU |
9445757517
selvamani@cmcvellore.ac.in |
| Dr Beela Sarah Mathew |
Regional Cancer Centre |
Medical College P.O, 695011
Thiruvananthapuram
KERALA |
9846520565
beelasmathew@gmail.com |
| Dr Sanjoy Chatterjee |
Tata Medical Centre |
Department - Radiation Oncology, Room no- HRG 02, Ground Floor, Phase 1, 14 Major Arterial Road (E-W), Kolkata
Kolkata
WEST BENGAL |
913366057773
sanjoy.chatterjee@tmckolkata.com |
| Dr Tabassum Wadasadawala |
Tata Memorial Centre |
Dr. E Borges Road, Parel, Mumbai-400 012 India.
Mumbai
MAHARASHTRA |
919324445303
twadasadawala@actrec.gov.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- II |
Approved |
| Institutional Review Board - Christian Medical College |
Approved |
| Institutional Review Board - Tata Medical Center |
Approved |
| Regional Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Radiotherapy (RT) |
49.5Gy in 18 daily fraction of 2.75Gy OR 36Gy in 6 twice-weekly fraction of 6Gy
|
| Intervention |
Radiotherapy (RT) Plus KORTUC |
49.5Gy in 18 daily fractions of 2.75Gy plus 5-6 intratumoural KORTUC injections twice-weekly
OR 36Gy in 6 twice-weekly fractions of 6Gy plus 4-5 intratumoural KORTUC injections twice-weekly
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient age 18 years and over.
Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases
Radical/high dose palliative RT required for lifetime control of local morbidities.
Patient physically and mentally fit for radical/high dose palliative RT.
Target tumour accessible for intra-tumoural injection.
Patient suitable/compliant with MRI protocol
At least one tumour diameter ≥30mm and ≤150mm measurable by ultrasound, MRI, CT or PET-CT
Patients with predicted life expectancy of 12 months or more.
Negative pregnancy test before start of RT in women of child bearing potential and an ability/ willingness to protect against pregnancy from consent and for 3 months post-RT.
Documented informed consent obtained. |
|
| ExclusionCriteria |
| Details |
Prior RT to the target area.
Maximum diameter of target tumour 150mm measurable by ultrasound, MRI, CT or PET-CT.
Anatomical location and/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus.
Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab and Denosumab (all endocrine therapies and bisphosphonates are allowed concomitantly; other cytotoxics and biological therapies apart from those mentioned above should be stopped 3 weeks prior to RT).
Pregnancy or nursing.
Hypersensitivity to any of the KORTUC ingredients.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To test efficacy
|
Complete tumour response based on best response assessed by contrast enhanced MRI, according to criteria
outlined in protocol, performed up to and including 12 months post-RT. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To further characterise efficacy & safety |
Overall survival at 6,12&24 months
Loco-regional recurrence,local progression-free survival & distant recurrence at 6, 12 & 24 months
Proportion of patients with either complete response on MRI up to & including 12 months or pathological complete response following tumour resection before 12 months.
Proportion of patients with partial response & stable
disease
Planned/unplanned tumour excision & pathological
response
Adverse events
Compliance with KORTUC administration |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/06/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is multi-centre, non-blinded, randomised trial with two groups comparing radiotherapy (RT) plus/minus radiation sensitizer.
Patients with poorly controlled symptoms of primary or recurrent locally advanced breast cancer requiring high dose RT for lifetime control of moderate or severe morbidities will be enrolled in the study.
Randomisation: Treatment allocation will be in a 1:1 ratio of RT alone versus same RT + KORTUC. Randomisation is performed by an interactive response technology (IRT) system.
Planned sample size globally is 184 subjects (92 in each randomised group). |