| CTRI Number |
CTRI/2025/07/090444 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| 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 on How Radiotherapy given prior to surgery Affects Recovery in Women Having Breast cancer and undergoing removal of the breast with Reconstruction |
|
Scientific Title of Study
|
A pilot study of assessing surgical morbidity of preoperative radiotherapy in
women undergoing whole breast reconstruction |
| Trial Acronym |
SUPER-RT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4751 Version 1.1 dated 05.05.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Homi Bhabha Block 1117, Tata Memorial Hospital, Dr E Borges Road, Parel (E) Mumbai, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02227405079 |
| Fax |
|
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Homi Bhabha Block 1117, Tata Memorial Hospital, Dr E Borges Road, Parel (E) Mumbai, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02227405079 |
| Fax |
|
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Homi Bhabha Block 1117, Tata Memorial Hospital, Dr E Borges Road, Parel (E) Mumbai, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02227405079 |
| Fax |
|
| Email |
twadasadawala@actrec.gov.in |
|
|
Source of Monetary or Material Support
|
| Intramural funding from Tata Memorial Hospital Dr. Ernest Borges road, , Parel, Mumbai. 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital Dr E Borges Road, Homi Bhabha Block 1117, Parel (E) 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) |
Room No 259 Radiation oncology Paymaster Shodhika Near Central Park, Sector 22, ,Kharghar 410210
Mumbai (Suburban)
MAHARASHTRA |
02227405000
twadasadawala@actrec.gov.in |
| Dr Tabassum Wadasadawala |
Tata Memorial Hospital |
Homi Bhabha Block Room no 1117 Department of Radiation Oncology Dr E Borges Road Parel 400012
Mumbai
MAHARASHTRA |
02224177000
twadasadawala@actrec.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MUMBAI |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE MUMBAI |
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 |
NIL |
NIL |
| Intervention |
Preoperative RT |
Radiotherapy will be given in patients planned for mastectomy with immediate autologous
breast reconstruction. With the aim to reduce the late effects of radiation on the autologous tissue. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Age greater than 18 years and up to 65 years
2. Planned for mastectomy and immediate autologous BR
3. Confirmed indication of post mastectomy RT (locally advanced breast cancer, and
multicentric and node positive operable breast cancer) |
|
| ExclusionCriteria |
| Details |
1. Inability to give informed consent
2. Any systemic therapy related toxicity affecting planning of locoregional therapy
3. Unwilling to comply with assessment schedules
4. Inflammatory breast cancer
5. Pregnancy associated breast cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of perioperative morbidity scored by Clavien Dindo. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of successful microvascular anastomosis using the internal mammary vessels
|
Intraoperative |
Incidence of successful skin pocket preservation during mastectomy
|
Intraoperative |
Incidence of Skin necrosis of the mastectomy flap
|
1 week |
| Overall rate of surgical complications |
8 and 12 weeks |
| Proportion of patients with Pathological complete response (pCR) |
2 weeks |
| Change in breast-related symptom |
Post RT between 8-12 weeks,
6 and 12 months |
| Change in patient satisfaction |
Post RT between 8-12 weeks,
6 and 12 months |
| Total duration of surgery in minutes. |
Immediate post surgery |
| Intraoperative Blood loss |
Intraoperative |
| Duration of hospital stay |
1 week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study intends to assess preoperative radiotherapy (RT)’s viability and surgical risk in women having mastectomy followed by immediate autologous whole breast reconstruction. Patients with breast cancer who need both a mastectomy and radiation therapy are eligible, as determined by multidisciplinary team decisions. Two to four weeks following the last round of neoadjuvant chemotherapy, preoperative radiotherapy is administered using either IMRT or conventional methods, with treatment volumes encompassing the breast and regional nodes as necessary. To allow for recovery and lower the risk of fibrosis, surgery is planned 4–6 weeks after RT and involves mastectomy and DIEP flap reconstruction. Because of the increased risk of necrosis after preoperative RT, intraoperative use of indocyanine green (ICG) helps evaluate the viability of skin flaps. According to institutional protocols, standard systemic therapies are still being used. Assessments of surgical outcomes, wound healing (using Clavien-Dindo and CDC criteria), patient-reported outcomes (BREAST-Q), cosmetic results, and documentation of complications like flap failure or infection are performed on patients at regular intervals for up to a year. Prior to a planned randomized controlled trial, the study aims to produce preliminary data regarding the safety and feasibility of preoperative RT in this context.
|