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CTRI Number  CTRI/2018/01/011300 [Registered on: 12/01/2018] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Multicatheter interstitial brachytherapy (MIBT) based accelerated partial breast irradiation (APBI) - dosimetric comparison with external beam radiotherapy and report on early outcomes in terms of toxicity and local control 
Scientific Title of Study   Multicatheter interstitial brachytherapy (MIBT) based accelerated partial breast irradiation (APBI) - dosimetric comparison with external beam radiotherapy and report on early outcomes in terms of toxicity and local control 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiron G 
Designation  Junior Resident 
Affiliation  KMC MANIPAL 
Address  DEPARTMENT OF RADIOTHERAPY AND ONCOLOGY, KMC MANIPAL, UDUPI, KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  9496817268  
Fax    
Email  drkirong@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Sharan 
Designation  Guide and HOD 
Affiliation  KMC MANIPAL 
Address  DEPARTMENT OF RADIOTHERAPY AND ONCOLOGY, KMC MANIPAL, UDUPI, KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  9448625116  
Fax    
Email  tk.sharan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kiron G 
Designation  Junior Resident 
Affiliation  KMC MANIPAL 
Address  DEPARTMENT OF RADIOTHERAPY AND ONCOLOGY, KMC MANIPAL, UDUPI, KARNATAKA

Udupi
KARNATAKA
576104
India 
Phone  9496817268  
Fax    
Email  drkirong@gmail.com  
 
Source of Monetary or Material Support  
Department Of Radiotherapy And Oncology, Department Of Surgery, KMC, MANIPAL 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not applicable 
Type of Sponsor  Other [Not Applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kiron G  Kasturba Medical College, Manipal  Room No 1, Ground Floor, Department Of Radiotherapy And Oncology, Department Of Surgery, KMC, MANIPAL, UDUPI, KARNATAKA-576104
Udupi
KARNATAKA 
9496817268

drkirong@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KMC, Manipal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Post Surgery For Breast Cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Patients eligible and willing to undergo APBI. The American Society for Radiation Oncology (ASTRO) recommendations for APBI include all of the following:
1. Age > 50 years
2. Tumor ≤ 3 cm
3. Histology: IDC Invasive Ductal Carcinoma
4. Negative Lymph node status
5. Negative resection margins
6. No evidence of Lympho-vascular invasion
7. No evidence of Extracapsular invasion
2. In addition, patients with features considered to be cautionary by guidelines (such as ages between 40-50 years, high grade disease, evidence of LVSI, etc.) who have been informed about the pros and cons of APBI and have voluntarily preferred undergoing the procedure will be taken up 
 
ExclusionCriteria 
Details  1. Patients unwilling for APBI
2. Positive surgical resection margins.
3. Other definite contraindications for APBI such as multiple nodes positive, neoadjuvant chemotherapy, multifocal/multicentric disease, etc.
4. Incomplete/inadequate information on relevant Organs at Risk on Planning CT images.
5. Patients in whom the implant was deemed as unacceptable (eg: gross miss of surgical cavity). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To dosimetrically compare normal tissue exposure and tumor coverage of IMRT among patients treated with MIBT based APBI  3 months from ethics committee clearance 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate local control rate following MIBT-APBI
2. To analyse toxicities of treatment
3. Record physician and patient perceived cosmetic outcomes of treatment 
3 months from ethics committee clearance 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/03/2018 
Date of Study Completion (India) 30/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/06/2019 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Radiation therapy (RT) is an integral component of local therapy following breast conservation surgery in patients with breast carcinomas. It is typically delivered to the Whole breast by teletherapy techniques ranging from conventional to Intensity Modulated RT (IMRT). The conventionally fractionated whole breast RT treatment regimen usually takes six weeks to complete. More recent hypofractionated EBRT schedules have managed to reduce the overall treatment time, but it still takes at least 3 weeks for the entire course treatment.

A relatively new technique called Accelerated partial breast irradiation (APBI) is becoming widely accepted among the radiation oncologists treating breast cancer as well as the patients. The rationale behind APBI is that most of the local recurrences develop in close proximity to tumour bed; therefore, treating only the vicinity of resection cavity could potentially provide for equivalent local control rates, while simultaneously reducing toxicity by lowering the overall irradiated volumes. Small treatment volumes also enable larger fractional dose, thereby drastically reducing overall treatment time to less than 1 week.

There is now evidence to suggest that APBI is a suitable alternative to WBRT for selected patients.(10,11)There are different approaches to APBI like Multicatheter interstitial brachytherapy (MIBT), Single/multichannel balloon and hybrid device brachytherapy (BT) and EBRT techniques such as 3D-Conformal RT (3D-CRT), IMRT, Volume modulated arc therapy (VMAT) and proton therapy (3, 4). There are research works clinically and/or dosimetrically comparing between various APBI techniques and with WBI. (5-8) This study plans to retrospectively compare the tumor coverage, and normal tissue exposure with IMRT in patients treated with MIBT at our center and to report on early outcomes in terms of toxicity and local control.

 
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