| CTRI Number |
CTRI/2023/06/053665 [Registered on: 08/06/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2023 |
| 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 ACUTE SIDE EFFECTS AND BREAST
COSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVING SHORT COURSE RADIOTHERAPY VERSUS VERY SHORT COURSE RADIOTHERAPY |
|
Scientific Title of Study
|
A COMPARATIVE STUDY EVALUATING ACUTE TOXICITY AND BREAST
COSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVING
MODERATE VERSUS EXTREME HYPOFRACTIONATED RADIOTHERAPY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SATYAJIT PRADHAN |
| Designation |
PROFESSOR, DEPT OF RADIATION ONCOLOGY |
| Affiliation |
MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC) |
| Address |
5TH FLOOR, DIRECTOR OFFICE, MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC), SUNDARPUR, VARANASI, UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
satyajit.pr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
LINCOLN PUJARI |
| Designation |
ASSOCIATE PROFESSOR, DEPT OF RADIATION ONCOLOGY |
| Affiliation |
MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC) |
| Address |
OPD 31, OPD BLOCK, DEPT. OF RADIATION ONCOLOGY, MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC), SUNDARPUR, VARANASI, UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
lincoln.pujari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRASHANTH GIRIDHAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC) |
| Address |
OPD 2, OPD BLOCK, DEPT. OF RADIATION ONCOLOGY, MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC), SUNDARPUR, VARANASI, UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
prashanth.jipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE (MPMMCC), VARANASI, UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| SAMAPIKA BHAUMIK |
Mahamana Pandit Madan Mohan Malaviya Cancer Center |
Dept. of Radiation Oncology, Mahamana Pandit Madan Mohan Malaviya Cancer Center, Sundarpur, Nariya, Varanasi, UP - 221005
Varanasi
UTTAR PRADESH |
9589018981
samapikabhaumik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MPMMC AND HBCH, VARANASI |
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 |
EXTREME HYPOFRACTIONATED RT IN EARLY STAGE BREAST CANCER PATIENTS |
ARM B OF THE STTUDY WILL INCLUDE POST OP EARLY BREAST CANCER PATIENT WHO WILL RECEIVE 26Gy/5#daily +boost of 12.5/5# daily (total 2 WEEKS of intervention) and we will assess and compare the acute toxicity, breast cosmesis and Skin changes & subcutaneous tissue changes with the comparator arm |
| Comparator Agent |
MODERATE HYPOFRACTIONATED RT IN EARLY STAGE BREAST CANCER PATIENTS |
ARM A OF THE STTUDY WILL INCLUDE POST OP EARLY BREAST CANCER PATIENT WHO WILL RECEIVE 40Gy/15#daily +boost of 12.5/5# daily (total 4 WEEKS of intervention)and we will assess and compare the acute toxicity, breast cosmesis and Skin changes & subcutaneous tissue changes with the INTERVENTION arm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Histologically proven invasive carcinoma of the breast cT1-T2 N0-1M0 and cT3N0 AJCC stage 1 & 2 patients following complete excision of the primary tumour by breast conservation surgery. There should be adequate surgical resection of primary (ink negative) and nodal disease (negative sentinel lymph node biopsy or adequate axillary sampling or dissection (yield atleast 10 nodes).
2. Written informed consent
3. Age - 18 to 70 years
4. Female gender
5. ECOG Performance status 0 - 2
6. Non-metastatic disease. |
|
| ExclusionCriteria |
| Details |
1. Any histopathology other than invasive carcinoma and DCIS.
2. Synchronous or metachronous malignancy.
3. Pregnant or lactating women.
4. Uncontrolled concurrent illness like DM, HTN, tuberculosis.
5. Evidence of distant metastasis.
6. Recurrent or residual disease.
7. Previous history of radiation to thoracic and neck area.
8. Patients not meeting dose volume constraints. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare acute toxicity in breast carcinoma patients treated with moderately Hypofractionated radiotherapy versus extreme hypofractionated radiotherapy. |
Weekly assessment of acute toxicity during radiotherapy at 4 weeks & 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To compare breast cosmesis in breast carcinoma patients treated with moderately hypofractionated radiotherapy versus extreme hypofractionated radiotherapy.
-Skin changes & subcutaneous tissue changes |
Cosmetic evaluation- baseline, end of RT, 6 months post RT & 1 year post RT. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
25/06/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response (Others) - CODED DATA SHEET, AFTER STUDY COMPLETION
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - proposals to be directed to: samapikabhaumik@gmail.com
- For how long will this data be available start date provided 01-04-2025 and end date provided 31-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A COMPARATIVE STUDY EVALUATING ACUTE TOXICITY AND BREAST COSMESIS IN EARLY STAGE BREAST CANCER PATIENTS RECEIVING MODERATE VERSUS EXTREME HYPOFRACTIONATED RADIOTHERAPY- Breast cancer is treated with surgery, chemotherapy, radiotherapy and hormonal agents. The techniques of radiotherapy available are varied and so are the dose schedules, with more than one standard dose schedules. In this study, we are comparing two standard radiation dose schedules. The 1st one treatment completes in 4 weeks and in the 2nd one treatment completes in 2 weeks. Both of them has been found to be similar in efficacy and toxicity in early stage breast cancer patients of western countries. We plan to evaluate the radiation schedules in terms of the acute toxicity and the breast cosmesis in our Indian population. We believe this study would enable us to take a more informed decision on the choice of dose schedule for the patients with early breast cancer in India. |