| CTRI Number |
CTRI/2026/01/100098 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the response of Radiotherapy in Inoperable Breast Cancer Patients not responding to Preoperative Chemotherapy. |
|
Scientific Title of Study
|
A prospective study to determine the disease response to Radiotherapy (34Gy/10 fractions) in
patients of Inoperable Carcinoma breast not responding to Neo-Adjuvant Chemotherapy and
factors influencing it. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1332-9013 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avni Saini |
| Designation |
Post Graduate Trainee |
| Affiliation |
Institute of Post Graduate Education and Research Kolkata |
| Address |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9811036266 |
| Fax |
|
| Email |
dravnisaini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrima Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Post Graduate Education and Research Kolkata |
| Address |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433824243 |
| Fax |
|
| Email |
chandrimab14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrima Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Post Graduate Education and Research Kolkata |
| Address |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433824243 |
| Fax |
|
| Email |
chandrimab14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Avni Saini |
| Address |
Department of Radiotherapy
Chest and Cancer Block
IPGMER and SSKM Hospital
244 AJC Bose Road Kolkata |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Post Graduate Education and Research Kolkata |
IPGMER and SSKM Hospital
244 AJC Bose Road Kolkata |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Avni Saini |
Institute of Post Graduate Medical Education and Research Kolkata |
Department of Radiotherapy
IPGMER and SSKM Hospital
244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL |
9811036266
dravnisaini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypo-fractionated Radiotherapy |
Hypo-fractionated Radiotherapy with 34 Grey in 10 fractions to PTV, one fraction a day, 5
fractions a week, over 2 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Histologically confirmed locally advanced or recurrent breast carcinoma deemed inoperable.
2. Patients unsuitable for surgery due to comorbidities, or patient refusal,3. Age: more than 18years.
4. ECOG performance status 0-3.
5. Stage of the disease T3/4, N positive, M positive or negative.
6. Patients not responding to neoadjuvant chemotherapy
7. Normal baseline complete blood counts, liver function tests, renal function tests, blood
sugar.
8. Patients who have received cardiological clearance with normal ECG and 2D
Echocardiography scans
9. Signed informed consent by the patient to participate in the study including willingness to
join the novel treatment approach. |
|
| ExclusionCriteria |
| Details |
1. Prior radiation therapy to the same breast or chest wall
2. Pregnant or lactating women.
3. Evidence of uncontrolled co-morbidities e.g. uncompensated respiratory, cardiac, hepatic
and renal issues.
4. Refusal to undergo radiation therapy
5. Any other malignancy in past 5 years
6. Patients with visceral crisis.
7. Participation in any other interventional study on breast carcinoma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluated based on the change in acute and late toxicity profiles before and after completion
of radiotherapy. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Disease response in terms of Clinical assessment by Investigators
2. Toxicity assessment as per RTOG criteria |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 seeks to establish the role of hypo-fractionated radiotherapy as a feasible and effective treatment modality for a difficult subset of inoperable and Neo-Adjuvant Chemotherapy non-responsive breast cancer patients, ultimately contributing to be enhanced clinical decision-making in such settings. This trial is an attempt to find the efficacy and tolerability in patients who has remained inoperable even after the Neo-Adjuvant Chemotherapy is completed. in a resource constrained high volume tertiary care centre like ours. |