| CTRI Number |
CTRI/2019/02/017411 [Registered on: 04/02/2019] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A pilot study of giving chemotherapy and radiotherapy concomitantly after breast cancer surgery |
|
Scientific Title of Study
|
A Pilot Study of Concurrent Chemotherapy and Radiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT) |
| Trial Acronym |
CONCERT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3155 v 2.0 dated 091018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Associate Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Tata Memorial Hospital
Dr E Borges Road,Homi Bhabha Block 1117, Parel (E)
Mumbai, India
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, PS 259,
Kharghar, Navi Mumbai, India
410210
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02227405079 |
| Fax |
02227405061 |
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Associate Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Tata Memorial Hospital
Dr E Borges Road,Homi Bhabha Block 1117, Parel (E)
Mumbai, India
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, PS 259,
Kharghar, Navi Mumbai, India
410210
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02227405079 |
| Fax |
02227405061 |
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Associate Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Tata Memorial Hospital
Dr E Borges Road,Homi Bhabha Block 1117, Parel (E)
Mumbai, India
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, PS 259,
Kharghar, Navi Mumbai, India
410210
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02227405079 |
| Fax |
02227405061 |
| Email |
twadasadawala@actrec.gov.in |
|
|
Source of Monetary or Material Support
|
| Intramural funding (Womens Cancer Initiative) from Tata Memorial Hospital |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Dr E Borges Road, Parel
Mumbai, India
400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tabassum Wadasadawala |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Kharghar, Navi Mumbai, India
410210
Raigarh
MAHARASHTRA |
02227405079
twadasadawala@actrec.gov.in |
| Dr Tabassum Wadasadawala |
Tata Memorial Hospital |
Tata Memorial Hospital
Dr E Borges Road, Parel
Mumbai, India
400012
Mumbai
MAHARASHTRA |
02224177000
twadasadawala@actrec.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-1 |
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 |
| Intervention |
Concurrent Chemoradiotherapy |
Concurrent chemoradiotherapy in adjuvant treatment of breast cancer |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Pathologically confirmed invasive breast cancer
2. Stage II-III invasive breast cancer (AJCC 8th edition)
3. Patients planned for taxane-based adjuvant chemotherapy and adjuvant radiotherapy after curative-intent surgery irrespective of her2 status and receipt of anti-her2 therapy
4. Patients fit to receive taxane based chemotherapy
5. Age > 18 years
6. Willing to provide venous blood sample
7. Consent for photograhic assessment in case of breast conservation
|
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity to taxanes
2. Patients meriting extended field radiotherapy (to internal mammary nodes and/or axillary nodes)
3. Bilateral breast cancer meriting radiotherapy to both sides
4. Unable or unwilling to give written informed consent
5. Unable or unwilling for regular follow up
6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs
7. Patient undergone immediate whole breast reconstruction
8. Patients receiving dose dense regimens.
9. Patients with prior irradiation of breast/mediastinum/neck
10. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the feasibility and safety of concurrent CTRT regimen in adjuvant treatment of breast cancer. |
Incidence of concurrent chemo-radiotherapy associated dose limiting toxicity will be assessed during as well as after treatment up to 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the compliance rate and incidence of severe toxicity; To study impact of concurrent regimen on patient Quality of life; To compare severe acute toxicity rates of the two schedules of taxanes: 3 weekly and weekly; Short term disease related outcomes of concurrent CTRT in terms of overall survival (OS), loco-regional failure-free survival (LRFFS), breast cancer specific survival (BCSS)
|
Study the impact of concurrent CTRT on global Quality of life scores up to 2 years post treatment; Disease free survival at 3 years; Breast cancer specific survival at 3 years; Overall survival at 3 years
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/02/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Abstract: https://doi.org/10.1016/j.ijrobp.2022.07.756
2. Article: https://doi.org/10.3332/ecancer.2023.1510 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, interventional, Phase 2 Pilot study to demonstrate feasibility and safety of concurrent CTRT in 60 patients of Ca Breast receiving adjuvant treatment at TMH and ACTREC. The primary outcome evaluates dose limiting toxicity and the secondary endpoints include late toxicity, quality of life and disease related outcome till 24 months. |