| CTRI Number |
CTRI/2017/08/009197 [Registered on: 01/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
30/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Postmastectomy Radiotherapy for breast cancer patients |
|
Scientific Title of Study
|
Assessment of acute toxicities and early local recurrences in Post mastectomy breast cancer patients by Accelerated Hypo Fractionated Radiotherapy, a single arm clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niranjan V |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Radiotherapy,
Regional cancer centre,
JIPMER,
Puducherrry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9840212349 |
| Fax |
|
| Email |
vijayaraghavan.niranjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niranjan V |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Radiotherapy,
Regional cancer centre,
JIPMER,
Puducherrry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9840212349 |
| Fax |
|
| Email |
vijayaraghavan.niranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niranjan V |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Radiotherapy,
Regional cancer centre,
JIPMER,
Puducherrry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9840212349 |
| Fax |
|
| Email |
vijayaraghavan.niranjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry 605006 |
|
|
Primary Sponsor
|
| Name |
Dr Parthasarathy V |
| Address |
Additional Professor and Head of the Departmenrt,
Department of radiotherapy,
Regional Cancer Centre,
POndicherry 605006 |
| Type of Sponsor |
Other [] |
|
|
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 Parthasarathy V |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of
Radiotherapy,Regional
Cancer Centre
Puducherry
Pondicherry
PONDICHERRY |
9443601748
dr_patchu2003@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing Radiation therapy for breast cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypofractionated Radiotherapy of 42.5 Gy in 16 fractionations |
Patients breast cancer who have underwent mastectomy will be recieving a total dose of 42.5 Gy in 16 divided fractions at the rate of 2.66 Gy per fractions for a duration of 3 weeks. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Biopsy proven patients of carcinoma breast who have underwent Modified Radical Mastectomy. |
|
| ExclusionCriteria |
| Details |
Patient with ischemic heart disease or other cardiac ailments.
Previous history or irradiation to chest wall.
Presence of metastasis to liver, brain, contralateral breast, contralateral lymph nodes, bones.
Patients who have underwent Breast Conservation Surgery.
ECOG performance status > 3
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the incidence of grade II and above acute radiation induced dermatitis |
from the start of radiation until 3 months post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
incidence of other radiation induced toxicities
local recurrence of the tumor
|
from the start of radiation until 1 year post treatment |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
01/02/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single arm clinical trial in which patients with breast cancer who have underwent Modified Radical Mastectomy will receive Post Mastectomy Radiotherapy [PMRT] with a dose of 42.5 Gy in 16 fractions over 3 weeks. The acute toxicities will be assessed using RTOG toxicity grading
scale. Late toxicity will be graded according to RTOG/EORTC Late Radiation
Morbidity Scoring Schema. |