| CTRI Number |
CTRI/2025/03/082659 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A feasibility study on accelerated radiotherapy in cancers of throat and voice box |
|
Scientific Title of Study
|
A Pilot study on moderate accelerated radiotherapy in locoregionally advanced squamous cell carcinomas of Hypopharynx and Larynx - a prospective feasibility study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sowmiya Sampathrajan |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute, Adyar, WIA |
| Address |
Department of Radiation oncology, IORT Building,Room no.48, Sardar patel road, Guindy
Chennai-600020
Chennai
TAMIL NADU
600020
India |
| Phone |
7042811034 |
| Fax |
|
| Email |
doctorsowmiyapgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sowmiya Sampathrajan |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute, Adyar, WIA |
| Address |
Department of Radiation oncology,room no.48, IORT Building
Sardar patel road, Guindy
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
7042811034 |
| Fax |
|
| Email |
doctorsowmiyapgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sowmiya Sampathrajan |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute, Adyar, WIA |
| Address |
Department of Radiation Oncology,,room no.48 IORT Building,Sardar patel road, Guindy
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
7042811034 |
| Fax |
|
| Email |
doctorsowmiyapgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute, Adyar (WIA)
Sardar patel road, Chennai 600020 |
|
|
Primary Sponsor
|
| Name |
Cancer Institute Adyar WIA |
| Address |
Cancer Institute, Adyar (WIA) Sardar patel road, Chennai 600020 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sowmiya Sampathrajan |
Cancer Institute, Adyar, WIA |
Department of Radiation oncology, IORT Building,Room no.48, Sardar patel road, Guindy
Chennai-600020
Chennai
TAMIL NADU |
7042811034
doctorsowmiyapgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Cancer Institute,WIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, (2) ICD-10 Condition: C329||Malignant neoplasm of larynx, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
radiation treatment |
extra fraction of radiation per week, i.e patient receives 6 days a week radiotherapy , one extra dose on saturday every week instead of regular 5 days a week treatment |
| Comparator Agent |
single arm study |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients of newly diagnosed locally advanced stage III-IV squamous cell carcinomas of hypopharynx and larynx subsite, not for surgery, eligible to receive Radical radiotherapy with or without chemotherapy.
2.Age between 18 to 75 years |
|
| ExclusionCriteria |
| Details |
1.Patients with distant metastatic disease
2.Those who have undergone surgery and recurrent disease status.
Patient is mentally incapacitated or has a significant emotional aspect |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary end point would be treatment completion rates (proportion of patients completing the planned treatment) for feasibility
2.The proportion of patients who develop Grade 3 and 4 toxicity as per RTOG/CTCAE criteria. |
The treatment completion rates (proportion of patients completing the planned treatment) will be assessed at the end of radiotherapy treatment
2.The proportion of patients who develop Grade 3 and 4 toxicity as per RTOG/CTCAE criteria will be assessed every week during radiotherapy, 6 weeks post therapy and then monthly once upto 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The proportion of patients developing complete response, partial response and progressive disease during follow up.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/04/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Trial is yet to start recruitment. Aim of the study is - To evaluate the tolerability and feasibility of moderate accelerated radiotherapy (6 fractions per week) in locoregionally advanced squamous cell carcinomas of Hypopharynx and Larynx undergoing radical radiotherapy with or without chemotherapy at our institute. Treatment plan- |