| CTRI Number |
CTRI/2019/11/022151 [Registered on: 26/11/2019] Trial Registered Prospectively |
| Last Modified On: |
23/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Advanced Radiotherapy in Carcinoma Breast. |
|
Scientific Title of Study
|
Adjuvant Radiotherapy in breast cancer using Volumetric Modulated Arc Therapy (VMAT) technique: dosimetric comparison with 3D-Conformal Radiotherapy, and report on clinical outcomes. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikunj Patil |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Radiotherapy and Oncology,Kasturba Medical College, Manipal Udupi, Karnataka, 576104
Udupi
KARNATAKA
576103
India |
| Phone |
9404712015 |
| Fax |
|
| Email |
drnikunj.work@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Sharan |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Radiotherapy and Oncology,Kasturba Medical College, Manipal Udupi, Karnataka, 576104
Udupi
KARNATAKA
576103
India |
| Phone |
9448625116 |
| Fax |
|
| Email |
tk.sharan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikunj Patil |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Radiotherapy and Oncology,Kasturba Medical College, Manipal Udupi, Karnataka, 576104
Udupi
KARNATAKA
576103
India |
| Phone |
9404712015 |
| Fax |
|
| Email |
drnikunj.work@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Madhav Nagar,Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Department of Radiotherapy and Oncology, Kasturba Medical College, Manipal Udupi, Karnataka, 576103 |
| Type of Sponsor |
Private medical college |
|
|
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 Nikunj Patil |
Kasturba Medical College |
OPD no 1, Shirdi Sai baba Block, Department of Radiotherapy and Oncology, Kasturba Medical College, Manipal Udupi, Karnataka, 576103
Udupi
KARNATAKA |
9404712015
drnikunj.work@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patients with breast cancer requiring adjuvant radiotherapy following either BCS or MRM, but cannot be adequately treated with 3D-CRT, and thereby require IMRT based RT planning. Criteria:
a.Tumor coverage V95 < 90%.
b.Homogeneity Index > 0.1.
c.V105 > 5% of the tumor.
d.V10 <15-20% of heart.
e.Ipsilateral lung dose <25%.
f.Internal mammary lymph node positive cases.
g.B/L breast cancer.
Willing to participate in the study and provides a voluntary informed consent. |
|
| ExclusionCriteria |
| Details |
1. Metastatic disease, and patients being considered for loco-regional radiotherapy with an intent to palliation.
2. History of prior radiation, connective tissue disorders or other comorbidities that could put the patient at higher risk of developing treatment related toxicities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dosimetric comparison of tumor coverage and normal tissue exposure between VMAT technique with conventional 3DCRT Technique in adjuvant radiotherapy for breast cancer. |
September 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To report the acute toxicities of treatment.
2.To evaluate local control rates following VMAT based EBRT.
3.Record patient-perceived cosmetic outcomes of treatment.
4.Quality of Life Study. |
Till September 2021 |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
29/11/2019 |
| 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="10"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational study.Patients with breast cancer in whom 3D-CRT is
deemed inadequate and are considered to be treated with VMAT technique, will be
enrolled if they meet the eligibility criteria. The treatment will be as per
the standard practice of the department. Demographic data and clinical details
will be collected from the out-patient records of the patients. In addition to
VMAT, a 3D-CRT plan will be generated for the same volumes for the purpose of
comparing the two techniques from dosimetric point-of-view. Various plan
related parameters will be recorded on the proforma. Patients will be evaluated during the course
of their treatment as per the routine practice, on a weekly basis, and their
acute toxicities will be recorded.
Following completion of radiotherapy, the
patients will be advised follow-up at 1 month and 3 monthly thereafter for 1.5
years. During follow-up, patients will be enquired regarding the presence and
severity of any local symptoms following treatment. They will be examined for
any evidence of recurrent disease and evaluated for toxicities. They will be
asked to grade the cosmetic outcome according to Harvard/RTOG Cosmesis grading
scale before treatment, just after completing treatment, at 1 month, 4 months,
7 months, and 10 months follow up. Quality of Life analysis will be done before starting treatment and 4 months after completion of treatment during regular follow up. |