| CTRI Number |
CTRI/2023/02/049783 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two radiation treatment schedules to reduce symptoms in advanced head and neck cancer patients |
|
Scientific Title of Study
|
Comparison of two palliative hypofractionated Radiotherapy schedules in patients of advanced Head and Neck Squamous cell Carcinoma - a single institutional prospective randomized study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DEBAPRIYO HALDER |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
DEPARTMENT OF RADIOTHERAPY , BURDWAN MEDICAL COLLEGE |
| Address |
DEPARTMENT OF RADIOTHERAPY
BURDWAN MEDICAL COLLEGE
BURDWAN
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9474315739 |
| Fax |
|
| Email |
debapriyohalder@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHISHEK BASU |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF RADIOTHERAPY |
| Address |
DEPARTMENT OF RADIOTHERAPY
BURDWAN MEDICAL COLLEGE
BURDWAN
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9830303459 |
| Fax |
|
| Email |
drabhishekbasu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEBAPRIYO HALDER |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
DEPARTMENT OF RADIOTHERAPY |
| Address |
DEPARTMENT OF RADIOTHERAPY
BURDWAN MEDICAL COLLEGE
BURDWAN
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9474315739 |
| Fax |
|
| Email |
debapriyohalder@gmail.com |
|
|
Source of Monetary or Material Support
|
| BURDWAN MEDICAL COLLEGE AND HOSPITAL,
BURDWAN |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [self funding] |
|
|
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 DEBAPRIYO HALDER |
BURDWAN MEDICAL COLLEGE AND HOSPITAL, RADIOTHERAPY OPD |
ROOM NO-103, RADIOTHERAPY OPD, DEPARTMENT OF RADIOTHERAPY, BURDWAN MEDICAL COLLEGE AND HOSPITAL,
BURDWAN,
PIN-713104
Barddhaman
WEST BENGAL |
9474315739
debapriyohalder@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, BURDWAN MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
QUAD Shot |
14 gray in 4 fractions over 2 days; 3.5 gray per fraction; 2 fractions per day atleast 6 hours apart; cycle to be repeated after 2 weeks |
| Comparator Agent |
Standard Palliative Radiation |
30 gray in 10 fractions over 2 weeks; 3 gray per fraction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Age between 18 to 80 years
-Histopathologically diagnosed as squamous cell carcinoma
-Cancer of head and neck involving the following sub-sites:-
o Oral cavity
o Oropharynx
o Hypo-pharynx
o Larynx
-De-novo or recurrent / refractory cases
-Clinically stage group III to IVC (AJCC 8th Edition)
-ECOG PS 0 to 3
-Deemed unsuitable for surgery / inoperable in a multidisciplinary tumour board
-Calculated life expectancy > 90 days
-Baseline Haemoglobin>9 gm/dl, ANC > 1500/µl, platelets > 1,00,000/µl
-Creatinine Clearance >30 ml/min
-Written informed consent |
|
| ExclusionCriteria |
| Details |
-Histopathology other than squamous cell carcinoma
-Pregnancy and lactation
-Uncontrolled severe comorbidities
-Severe dyselectrolytaemia
-Sub-sites other than Oral cavity, Oropharynx, Hypo-pharynx and Larynx
-Major psychiatric illness making the patient incapable of following medical advice
-Prior head and neck radiotherapy within the last 6 months
-Prior head and neck surgery within the last 3 months
-Concomitant or prior chemotherapy / targeted therapy / immunotherapy within the last 2
weeks
-Inability to receive palliative radiotherapy due to patient’s clinical condition, positional
or immobilization issues or other reasons
-Unwillingness to undergo palliative radiotherapy
-Refusal to provide informed consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| QUAD SHOT IS AN EFFECTIVE PALLIATIVE REGIMEN FOR ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA. |
AT BASELINE, DAY 3, DAY 7, DAY 28, SUBSEQUENTLY IN EVERY MONTHS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
22/02/2023 |
| 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="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Aggressive radical treatment may not be suitable for many patients of advanced head and neck cancers. Palliative Hypofractionated radiotherapy plays a pivot role for symptoms palliation. Here we compare between two palliative hypofractionated radiotherapy schedules of standard or conventional and Quad Shot regimen.
|