| CTRI Number |
CTRI/2022/11/047451 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective and Prospective Non randomized study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tubarial Salivary glands : Radiation Dosimetry and sparing |
|
Scientific Title of Study
|
Dosimetric and Feasibility study of Sparing of Tubarial Salivary Glands in
Head and Neck Cancer patients treated with Definitive Radiotherapy, with or
without Concurrent Chemotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Budrukkar |
| Designation |
Professor and Radiation Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1118,Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Room No 1118,Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
0222417152 |
| Fax |
|
| Email |
ashwini.budrukkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Budrukkar |
| Designation |
Professor and Radiation Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1118,Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Room No 1118,Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
0222417152 |
| Fax |
|
| Email |
ashwini.budrukkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjan Subramani |
| Designation |
Junior Resident III |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 205 ,2nd Floor ,Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Room No 205 ,2nd Floor ,Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
0222417152 |
| Fax |
|
| Email |
ranjanst07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr E Borges Road
Parel Mumbai
MAHARASHTRA
400012
India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Ashwini Budrukkar |
Tata Memorial Hospital |
Dr E Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
0222417152
ashwini.budrukkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. WHO PS 0,1
2. Non-Nasopharyngeal and Non PNS/Nasal cavity Head and Neck Cancers
3. Definitive Radiotherapy.
4. For prospective study- patients with no overlap of the planning target volume (PTV)
with tubarial glands will be considered |
|
| ExclusionCriteria |
| Details |
1. WHO PS >2
2. Nasopharyngeal tumors
3. PNS tumors
4. Post op HNC
5. Post NACT
6. Re RT
7. If Treating RPLN
8. Post pharyngeal wall tumors
9. Oropharyngeal tumors extending into Nasopharynx |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Primary endpoint: Dosimetry of Tubarial glands
2. Secondary end point: Late Xerostomia, locoregional control |
PSMA PETCET at baseline and after 6 months of treatment completion ( only of prospective participants ) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
22/11/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study is not yet initiated will start once CTRI registration is done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radiotherapy of head and neck cancer is known to cause Xerostomia as a long term side effect. Over the time from conventional 2D Radiotherapy to 3D CRT to IMRT, it has been seen that with advance in technology the incidence of radiation induced Xerostomia and the severity has been reduced to a great extent. Advanced technique RT in current practice has shown to reduce the dose to the salivary glands without compromising disease outcome. With the newly discovered tubarial salivary glands, this study will assess dosimetry of tubarial glands and effect of radiation on the glands in patients of head and neck cancer treated with radiotherapy with or without chemotherapy |