| 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 |
|
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Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post Surgery For Breast Cancer, |
|
|
Intervention / Comparator Agent
|
|
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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). |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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)?
|
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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. |