| CTRI Number |
CTRI/2025/01/078980 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Types of Radiation Therapy for Early-Stage Breast Cancer: Partial vs. Whole Breast Irradiation |
|
Scientific Title of Study
|
Prospective Randomised Study Comparing Accelerated Partial Breast Irradiation with Whole Breast Irradiation By 3 Dimensional Conformal Radiotherapy In Patients With Early Stage Breast Cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monsu Rathod |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9879611898 |
| Fax |
|
| Email |
monsurathod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Budhi Singh Yadav |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815981176 |
| Fax |
|
| Email |
drbudhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monsu Rathod |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9879611898 |
| Fax |
|
| Email |
monsurathod@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiotherapy and Oncology, Room no. 54, Nehru Hospital Extension,
Postgraduate Institute of Medical Education and Research(PGIMER), Sector 12, Chandigarh, PIN code - 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monsu Rathod |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Department of Radiotherapy and Oncology, Room no. 54, Nehru Hospital Extension, Postgraduate Institute of Medical Education and Research(PGIMER), Sector 12, Chandigarh, PIN code - 160012
Chandigarh
CHANDIGARH |
9879611898
monsurathod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
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 |
Accelerated partial breast irradiation |
One group will receive radiotherapy by accelerated partial breast irradiation with a dose of 22.5Gy at 7.5Gy per fraction over 3 days. |
| Comparator Agent |
Whole breast irradiation |
One group will receive radiotherapy by whole breast irradiation with a dose of 26Gy at 5.2Gy per fraction over 5 days. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Tumor size T1-T2
2. Nodes negative
3. Non metastatic
4. Negative surgical margin
5. Unicenteric
6. Unifocal
7. Lymphovascular invasion absent
8. No neoadjuvant chemotherapy given
|
|
| ExclusionCriteria |
| Details |
1. Tumor size (T3,T4)
2. Positive nodes
3. Metastatic
4. Positive surgical margin
5. Multicentric
6. Multifocal
7. Lobular carcinoma in situ
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute radiation toxicity after radiotherapy treatment |
At 1 month, 2 months and 3 months after radiotherapy treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cosmesis |
At 3 months, 6 months and 9 months after radiotherapy treatment |
| Late toxicity |
At 6 months and 9 months after radiotherapy treatment |
| Quality of life |
At 3 months and 6 months after radiotherapy treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Radiotherapy is an essential treatment modality for breast cancer in women. In this study, patients with early stage breast cancer post breast conserving surgery will receive radiotherapy by either accelerated partial breast irradiation with a dose of 22.5Gy in 3 fractions or whole breast irradiation with a dose of 26Gy in 5 fractions by using 3 dimensional conformal radiotherapy technique by randomizing patients in 2 arms. We aim to assess and compare acute toxicity, cosmesis and late toxicity in both arms. Also, we will assess quality of life in the patients. |