| CTRI Number |
CTRI/2025/09/094933 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between 2 types of courses of radiotherapy in Post operative female Breast Cancer patients. |
|
Scientific Title of Study
|
A Prospective Randomised Study To Compare The Outcome Between Conventional Radiotherapy And Hypo-Fractionated Radiotherapy Following Modified Radical Mastectomy in Female Breast Cancer Patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mudunuri Lakshmi Priyanka |
| Designation |
First year Post Graduate Resident |
| Affiliation |
IPGMER and SSKM HOSPITAL |
| Address |
Room no.4,Department of Radiotherapy, IPGMER AND SSKM HOSPITAL,244, A.J.C. Bose Road, Kolkata 700 020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9110559599 |
| Fax |
|
| Email |
mudunurilakshmipriyanka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amitabha Manna |
| Designation |
Professor |
| Affiliation |
IPGMER and SSKM HOSPITAL |
| Address |
Room no.4, Department of Radiotherapy,IPGMER,SSKM HOSPITAL, 244, A.J.C. Bose Road, Kolkata 700 020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433009577 |
| Fax |
|
| Email |
amitavamanna1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amitabha Manna |
| Designation |
Professor |
| Affiliation |
IPGMER and SSKM HOSPITAL |
| Address |
Room no.4,Department of Radiotherapy, IPGMER,SSKM HOSPITAL, 244, A.J.C. Bose Road, Kolkata 700 020
WEST BENGAL
700020
India |
| Phone |
9433009577 |
| Fax |
|
| Email |
amitavamanna1965@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER AND SSKM HOSPITAL ,Kolkata,70020, India. |
|
|
Primary Sponsor
|
| Name |
Mudunuri Lakshmi Priyanka |
| Address |
Department of Radiotherapy, IPGMER AND SSKM HOSPITAL , Kolkata,70020, India. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Suranjan Maitra |
IPGMER and SSKM HOSPITAL |
Room no.4,Department of Radiotherapy, 244, A.J.C. Bose Road, Kolkata 700 020
Kolkata
WEST BENGAL |
9933099901
suranjanmaitra9@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 |
Conventional Radiotherapy in Post MRM Breast Cancer patients |
Arm A-50 Gy per 25 fractions,2 Gy per fraction, 1 fraction per day for 5 days in a week |
| Comparator Agent |
Hypo-fractionated radiotherapy in Post MRM Patients |
Arm B-40 Gy in 15 fractions,2.67 Gy per fraction,1 fraction per day for 5 days in a week |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Study participants shall be selected according to the following criteria:
1. Patients with proven Histopathological report.
2. Age between 20 - 70 years.
3. Stage - T1 -T2 Node positive Disease, Any T3/above, any node positive, Post Modified Radical Mastectomy.
4.Patient with adequate Lung function, Liver function, Cardiac function, and haematological parameter.
|
|
| ExclusionCriteria |
| Details |
1. Any earlier chest wall radiation
2. Any Breast Conservation Surgery
3. Very early-stage node negative Breast Disease
4. H/o Any other malignancies within first 5 years of including breast cancer
5. Any uncontrolled comorbidities and collagen vascular diseases.
6. Metastatic Disease
7.Local recurrence.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) To compare the loco regional failure between 2 arms.
b) To compare acute toxicities as per RTOG/CTCAE v5.0 criteria between 2 arms.
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare distant disease-free survival between 2 arms. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="6"
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
|
The trial is for comparison of 2 regimes of Radiotherapy i.e. 50 GY in 25 fractions in one arm and 40 GY in 15 fractions in other arm ,in Post MRM Female Breast Cancer Patients to see the Locoregional failures and toxicities.Toxicities are compared using RTOG/CTCAE v5.0 criteria. |