| CTRI Number |
CTRI/2018/04/013008 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying of two different techniques of radiation therapy in breast cancer patients after tumor excision surgery.
|
|
Scientific Title of Study
|
Comparison of sequential and simultaneous integrated boost hypofractionated radiotherapy in patients with breast cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shipra Gupta |
| Designation |
Junior resident |
| Affiliation |
PGIMER |
| Address |
Radiotherapy department, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8527216552 |
| Fax |
|
| Email |
shiprag184@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Budhi Singh Yadav |
| Designation |
Associate professor |
| Affiliation |
PGIMER |
| Address |
Radiotherapy department, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815981176 |
| Fax |
|
| Email |
drbudhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Budhi Singh Yadav |
| Designation |
Associate professor |
| Affiliation |
PGIMER |
| Address |
Radiotherapy department, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815981176 |
| Fax |
|
| Email |
drbudhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research, sector 12, chandigarh. 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Post graduate institute of medical education and research, sector 12, Chandigarh. |
| 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 Shipra gupta |
PGIMER |
Radiotherapy department, Post graduate institute of research and technology,Chandigarh
Chandigarh
CHANDIGARH |
8527216552
shiprag184@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
STABLE, FIT FOR TREATMENT, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A |
Simultaneous integrated boost
IMRT.
Total duration of radiation treatment will be 2 weeks.
one treatment fraction per day.
Dose will be 34 Gy to whole breast along with 40 Gy to the cavity simultaneously. |
| Comparator Agent |
Arm B |
Sequential boost IMRT.
Total duration of radiation treatment will be 2 weeks and two days.
Treatment fraction will be one per day. Dose will be 34 Gy to whole breast followed by 8Gy boost to the cavity. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
BREAST CANCER PATIENTS AFTER BREAST CONSERVING SURGERY |
|
| ExclusionCriteria |
| Details |
patients with poor KPS (performance status )
patients with double malignancy
patients with history of prior radiation
patients >70 years of age |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dosimetry and cosmetic outcomes and acute toxicities
|
Post radiation, 1 month, 3 months, 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Late toxicities, locoregional control, TOXICITIES, disease free survival, event free survival, overall survival. |
immediately post radiation, 1 month post radiation, 3 month post radiation, 6 month post radiation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/05/2017 |
| 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
|
Breast irradiation has reduced the rate of local
recurrence significantly in case of breast cancer which have undergone breast
conservative surgery. The recurrence of cancer is most likely in the
region surrounding the original tumor, therefore addition of boost irradiation
to the tumor bed after whole breast irradiation has been shown to further
improve local control. Conventionally the radiation treatment is delivered in a sequential manner of whole breast radiation followed by boost dose delivery. While now with the introduction of volumetric
arc therapy (VMAT) technique, simultaneous irradiation of tumour bed is also
possible with the radiation of whole breast. It helps in achieving minimal
doses to the organs at risk. The simultaneous boost technique will be compared with sequential boost where the boost dose will be delivered after the delivery of whole breast radiation. Doses will be studied in both the arms in terms of target coverage, homogenity and doses to organs at risk. The radiation treatment has cosmetic
effects on the treated breast. The study will assess the cosmetic
effects on the treated breast as compared to the untreated breast. Cosmetic effects will be assessed by both subjective and objective methods. |