| CTRI Number |
CTRI/2024/10/075270 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of St-IMRT and do-IMRT in head and neck cancer: improving radiation induce dysphagia |
|
Scientific Title of Study
|
Improving post radiation dysphagia by limiting dose to dysphagia aspiration related structure (DARS) |
| Trial Acronym |
DARS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Upadhyay |
| Designation |
Assistant Professor |
| Affiliation |
SRMS IMS Hospital |
| Address |
RR Cancer Centre
Radiation oncology Department
Shri Ram Murti Smarak Institute Of Medical Science Hospital
Bhojpura
Bareilly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9999904576 |
| Fax |
|
| Email |
prachiupadhyay20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachi Upadhyay |
| Designation |
Assistant Professor |
| Affiliation |
SRMS IMS Hospital |
| Address |
RR Cancer centre
Radiation Oncology Department
Shri Ram Murti Smarak Institute of Medical Science Hospital
Bhojipura
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9999904576 |
| Fax |
|
| Email |
prachiupadhyay20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Upadhyay |
| Designation |
Assistant Professor |
| Affiliation |
SRMS IMS hospital |
| Address |
RR Cancer Centre
Radiation Oncology department
Shri Ram Murti Samark Institute of Medical Sciences hospital
Bhojipura
Bareilly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9999904576 |
| Fax |
|
| Email |
prachiupadhyay20@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRMS IMS
Bhojipura
Bareilly
Uttar Pradesh
India
243202 |
|
|
Primary Sponsor
|
| Name |
Dr Prachi Upadhyay |
| Address |
SRMS IMS Hospital
Bhojipura,Nainital-Bareilly Road
Bareilly
Uttar Pradesh
India
pincode 243202 |
| Type of Sponsor |
Other [self] |
|
|
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 Prachi Upadhyay |
SRMS IMS |
RR CANCER CENTRE
Radiation Oncology Department
SRMS IMS hospital
Bhojipura
Nainital-Bareilly road
Bareilly
UTTAR PRADESH |
9999904576
prachiupadhyay20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMS IMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dysphagia-optimised intensity modulated radiotherapy (do-IMRT) |
patients with oro-laryngopharyngeal carcinoma will be treated in this group with radical chemo-radiotherapy with IMRT with dose constraints to dysphagia aspiration related structures. Prescription dose will be 70 Gy in 35 fractions for 7 weeks 5 days a week along with concurrent chemotherapy once a week. |
| Comparator Agent |
standard intensity modulated radiotherapy (st-IMRT) |
patients with oro-laryngopharngeal carcinoma will be treated in this group with radical chemo-radiotherapy with IMRT without any dose constraints to dysphagia aspiration related structures. Prescription dose will be 70 Gy in 35 fractions for 7 weeks 5 days a week along with concurrent chemotherapy once a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven non-metastatic oro-larynopharyngeal carcinoma, Karnofsky performance score more than 70 , normal haemogram, renal function tests, liver function tests and those who can follow and understand study related advice and are willing to give consent. |
|
| ExclusionCriteria |
| Details |
patient with prior or synchronous malignancy, prior treated with radiotherapy, metastatic oro-larynopharngeal carcinoma, patient underwent surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether reducing the dose to dysphagia aspiration related structures with dysphagia optimized intensity modulated radiotherapy (do-IMRT) will improve in long term swallowing function without compromising any tumor control or disease specific survival. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| asses quality of life and factors associated with dysphagia |
3 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/10/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study would be prospective randomised controlled trial for patients undergoing primary chemo-radiotherapy for T1-4, N0-3, M0 Oro-larynopharyngeal cancers. Complete enumeration will be used. Therefore, all the patients coming to the R.R Centre cancer; SRMS IMS hospital,Bareilly, Uttar Pradesh which are falling in inclusion & exclusion criteria will be considered the sample.All patients will be randomised (1:1 ratio) to either standard Intensity Modulated Radiotherapy or dysphagia optimised Intensity Modulated Radiotherapy. Radiotherapy doses will be same in both groups i.e., 70 Gy in 35 fractions over 7 weeks However, patients allocated to do-IMRT group, dose constraints will be given to DARS, and no dose constraints will be given in standard Intensity Modulated Radiotherapy group. |