| CTRI Number |
CTRI/2025/03/082834 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dysphagia-optimised intensity modulated radiotherapy versus standard intensity modulated radiotherapy in head and neck cancer cases.
kindly note since we are comparing two advanced radiotherapy techniques, this is the simplest public title that can be added.
|
|
Scientific Title of Study
|
Dysphagia-Optimised Intensity Modulated Radiation Therapy vs Standard Intensity Modulated Radiation Therapy in post-operative cases of oral cavity carcinoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lahunshisha Kharbuli |
| Designation |
Junior Resident |
| Affiliation |
Sir Sunderlal Hospital,Institute of Medical Sciences, BHU. |
| Address |
Department of Radiotherapy & Radiation Medicine, Sir Sunderlal Hospital,Institute of Medical Sciences, BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9485317725 |
| Fax |
|
| Email |
lahunkharbuli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Mishra |
| Designation |
Professor |
| Affiliation |
Sir Sunderlal Hospital,Institute of Medical Sciences, BHU. |
| Address |
Department of Radiotherapy & Radiation Medicine, Sir Sunderlal Hospital,Institute of Medical Sciences, BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7704909900 |
| Fax |
|
| Email |
hmsra1801@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lahunshisha Kharbuli |
| Designation |
Junior Resident |
| Affiliation |
Sir Sunderlal Hospital,Institute of Medical Sciences, BHU. |
| Address |
Department of Radiotherapy & Radiation Medicine, Sir Sunderlal Hospital,Institute of Medical Sciences, BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9485317725 |
| Fax |
|
| Email |
lahunkharbuli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005,Uttar Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India |
| Address |
Department of Radiotherapy & Radiation Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi- 221005, Uttar Pradesh, India. |
| Type of Sponsor |
Government 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 Lahunshisha Kharbuli |
Institute of Medical Sciences, BHU |
Department of Radiotherapy & Radiation Medicine, Sir Sunderlal Hospital,Institute of Medical Sciences, BHU.
Varanasi
UTTAR PRADESH |
09485317725
lahunkharbuli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Sciences Institutional Ethics Committee Varanasi 221005 |
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
|
| Type |
Name |
Details |
| Intervention |
Dyphagia Optimised Intensity Modulated Radiotherapy (DO-IMRT) |
For patients with oral cavity carcinoma, the intervention arm will be treated with Dysphagia-Optimised Intensity Modulated Radiotherapy technique |
| Comparator Agent |
Standard Intensity Modulated Radiotherapy (S-IMRT) |
For patients with oral cavity carcinoma,the comparator arm will be treated with Standard Intensity Modulated Radiotherapy technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven post-operative oral cavity carcinoma.
Squamous-cell carcinoma histology.
Age 18-70 years of either sex.
pT1-pT4, N0-3,M0.
ECOG of 0-2.
Adequate hematologic, renal and hepatic function.
|
|
| ExclusionCriteria |
| Details |
Pre-existing swallowing dysfunction.
Any synchronous or metachronous malignancy.
Patients receiving neo-adjuvant chemotherapy.
Prior chemotherapy and /or radiotherapy to head and neck region.
Incomplete surgery or R2 resection
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute Toxicity |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Late toxicity.
Disease free survival
Overall survival
Loco-regional control.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
30/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/03/2025 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lahunkharbuli@gmail.com].
- For how long will this data be available start date provided 31-12-2024 and end date provided 31-01-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Surgery is the mainstay of treatment for resectable oral cavity cancer. However, patients with poor prognostic factors are also offered adjuvant RT with or without CT. With combined modality treatment, patients have to suffer from dysphagia especially because of irradiation of dysphagia aspiration related structures(DARS) during RT. With modern RT techniques like IMRT, doses to DARS and thus subsequently swallowing dysfunction could be minimized. Patients of both gender of the age group 18-70 years will be included. Patients with prior Chemotherapy and/or Radiotherapy or synchronous malignancy will be excluded. The present study is a randomized controlled study and the study aims to compare two different IMRT techniques i.e., dysphagia optimised IMRT (DO-IMRT) v/s standard IMRT (S-IMRT) in patients of oral cavity cancer who will be receiving adjuvant RT with or without Concurrent CTH. The primary end point is acute toxicity and the secondary end points are loco-regional control, disease-free survival, quality of life, late toxicty and overall survival. |