| CTRI Number |
CTRI/2025/02/080216 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Three weeks versus One week radiotherapy regimens in breast cancer patients. |
|
Scientific Title of Study
|
Comparative evaluation of three-weeks versus one week-adjuvant postoperative radiotherapy regimens in breast cancer patients using intensity modulated radiotherapy technique : A randomized controlled study. |
| 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 Sivaranjani P |
| Designation |
Post graduate |
| Affiliation |
All India Institute Of Medical sciences |
| Address |
Department Of Radiation Oncology, All India Institute Of Medical Sciences , Bathinda.
Bathinda
PUNJAB
151001
India |
| Phone |
7708686862 |
| Fax |
|
| Email |
sivaranjani738@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Marcus Bhatty |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical sciences |
| Address |
Department Of Radiation Oncology, All India Institute Of Medical Sciences , Bathinda.
Bathinda
PUNJAB
151001
India |
| Phone |
9478280097 |
| Fax |
|
| Email |
sapnamarcus@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna Marcus Bhatty |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department Of Radiation Oncology, All India Institute Of Medical Sciences , Bathinda.
Bathinda
PUNJAB
151001
India |
| Phone |
9478280097 |
| Fax |
|
| Email |
sapnamarcus@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences , Bathinda , Punjab , India Pin code : 151001 |
|
|
Primary Sponsor
|
| Name |
Dr Sivaranjani |
| Address |
Department Of Radiation Oncology, All India Institute of Medical Sciences , Bathinda , Punjab 151001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sivaranjani |
All India Institute Of Medical sciences , Bathinda |
Department Of Radiation Oncology,All India Institute of Medical Sciences , Bathinda 151001
Bathinda
PUNJAB |
7708686862
sivaranjani738@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
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 |
Arm A |
Patients will be given 40Gy in 15 fractions in 3 weeks |
| Intervention |
Arm B |
Patients will be given 26Gy in 5 fractions in 1 week |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All biopsy proven post-operative early and locally advanced invasive carcinoma breast patients. |
|
| ExclusionCriteria |
| Details |
Stage 4 disease
Metastatic carcinoma breast
Pregnancy and lactation
Bilateral breast tumours
Contraindication to radiotherapy eg: collagen vascular disorders
History of prior radiation therapy to chest wall |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary end point is ipsilateral breast tumour relapse |
Patients will be assessed clinically for loco-regional control rate at the end of treatment , 3 months and 6 months after completion of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acute and Sub-acute toxicities and loss of patient compliance . |
Toxicity assesment will be done weekly during treatment and at 2 weeks and 4 weeks after treatment. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="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
|
All biopsy proven postoperative early and locally advanced invasive breast carcinoma patients presenting at the outpatient department of Radiation Oncology will be enrolled in the study as per the inclusion criteria .A detailed history and clinical examination will be done along with baseline routine blood investigations and imaging. Patients will be explained about the need for post-operative radiotherapy and study details will be explained in detail and written informed consent will be taken. Patients will be allocated into two arms based on computer generated random tables. Patients in arm A will receive RT dose of 40Gy in 15 fractions in 3 weeks. Patients in arm B will receive RT dose of 26Gy in 5 fractions in 1 week. Patients will be assessed for acute and late toxicities weekly during treatment , 2 weeks and 4 weeks after treatment. Patients will be called for follow up after 1 month ,3 months and 6 months after completion of treatment and will be monitored for loco-regional control rate and documented . |