| CTRI Number |
CTRI/2024/12/077538 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the Dosimetric Effects of Sequential and Simultaneously-Integrated Boost in Breast Cancer Patients After Breast-Conserving Surgery |
|
Scientific Title of Study
|
Dosimetric Evaluation of Sequential Boost versus Simultaneously-Integrated
Boost in Patients with Breast Cancer Post Breast-Conserving Surgery |
| 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 Rahul Thakur |
| Designation |
DNB Junior Resident Radiation Oncology |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Max Super Speciality Hospital, W-3, Ashok Marg, Sector-1, Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9137861277 |
| Fax |
|
| Email |
thenativedoctor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashi Agrawal |
| Designation |
Associate Director Radiation Oncology |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Max Super Speciality Hospital, W-3, Ashok Marg, Sector-1, Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
09891483550 |
| Fax |
|
| Email |
drrashi.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashi Agrawal |
| Designation |
Associate Director Radiation Oncology |
| Affiliation |
Max Super Specialty Hospital |
| Address |
Max Super Speciality Hospital, W-3, Ashok Marg, Sector-1, Vaishali
UTTAR PRADESH
201012
India |
| Phone |
09891483550 |
| Fax |
|
| Email |
drrashi.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, W-3, Ashok Marg, Sector-1, Vaishali, Ghaziabad, Uttar Pradesh 201012 |
|
|
Primary Sponsor
|
| Name |
Dr. Rahul Thakur |
| Address |
Max Super Speciality Hospital, W-3, Ashok Marg, Sector-1, Vaishali, Ghaziabad, Uttar Pradesh 201012 |
| 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 Rahul Thakur |
Max Super Specialty Hospital W-3, Sector-1, Vaishali |
Department of
Radiation Oncology ,
Tower 1, Lower Basement, Max Super Specialty Hospital W-3, Sector-1, Vaishali
Ghaziabad
UTTAR PRADESH |
9137861277
thenativedoctor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Age more than 18 years
Female patients
Biopsy proven invasive breast cancer
Post operative breast cancer patients having
standard indication of radiation therapy |
|
| ExclusionCriteria |
| Details |
Prior radiotherapy to breast
Recurrent disease
Metastatic disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the dosimetric plans in patients treated with two distinct boost techniques
i.e. SIB and SEQBs |
To evaluate the dosimetric plans in patients treated with two distinct boost techniques
i.e. SIB and SEQBs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the dose received by Planning Target Volume (PTV) and Organs at Risk
(OAR) during IMRT and HT techniques in breast cancer patients treated via:
a. SIB plan and b. SEQBs plan
|
To evaluate the dose received by Planning Target Volume (PTV) and Organs at Risk
(OAR) during IMRT and HT techniques in breast cancer patients treated via:
a. SIB plan and b. SEQBs plan
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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) |
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
|
Radiation therapy has been an integral part of the management of Breast Cancer (BC). Radiation to Breast is complicated by the anatomy and relationship of target volumes with nearby organs at risk (OARs). With advances in technology, various techniques such as Intensity Modulated Radiation Therapy (IMRT) and Helical Tomotherapy (HT) have led to better coverage and conformity of target volumes and side by side, reduction in dose to OARs and thereby reducing the toxicity profile. In this study, we aim to analyse the dosimetric data of our institute comparing Sequential Boost (SEQB) with Simultaneously-Integrated Boost (SIB) plans of our patients treated with IMRT and HT treatment techniques. |