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CTRI Number  CTRI/2026/01/101377 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between a 6 days per week versus 5 days per week radiotherapy schedule with weekly chemotherapy in head and neck cancer patients 
Scientific Title of Study   Comparative evaluation of Accelerated Radiotherapy with concurrent Chemotherapy versus conventional fractionation chemoradiotherapy in head and neck cancers using Volumetric Modulated Arc Therapy: A Prospective Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Bose 
Designation  Junior Resident 
Affiliation  All India Instituteof Medical Sciences, Bathinda 
Address  Room 4011, Ground floor D Block , Out Patient Department, All India Institute of Medical Sciences, Bathinda
All India Institute of Medical Sciences, Mandi Dabwali Road , Bathinda
Bathinda
PUNJAB
151001
India 
Phone  8777531744  
Fax    
Email  drsnehabose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sneha Bose 
Designation  Junior Resident 
Affiliation  All India Instituteof Medical Sciences, Bathinda 
Address  Room 4011, Ground floor D Block , Out Patient Department, Department of Radiation Oncology, All India Institute of Medical Sciences, Bathinda
All India Institute of Medical Sciences, Mandi Dabwali Road , Bathinda
Bathinda
PUNJAB
151001
India 
Phone  8777531744  
Fax    
Email  drsnehabose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sneha Bose 
Designation  Junior Resident 
Affiliation  All India Instituteof Medical Sciences, Bathinda 
Address  Room 4011, Ground floor D Block , Out Patient Department, All India Institute of Medical Sciences, Bathinda
All India Institute of Medical Sciences, Mandi Dabwali Road , Bathinda
Bathinda
PUNJAB
151001
India 
Phone  8777531744  
Fax    
Email  drsnehabose@gmail.com  
 
Source of Monetary or Material Support  
All India Institiute of Medical Sciences, Bathinda, Punjab - 151001, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Bathinda 
Address  All India Institute of Medical Sciences, Mandi Dabwali Road, Bathinda 151001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sneha Bose  All India Institute of Medical Sciences, Bathinda  Room 4011, Ground floor D Block, Out Patient Department, Department of Radiation Oncology, All India Institute of Medical Sciences, Bathinda, Mandi Dabwali Road
Bathinda
PUNJAB 		 8777531744

drsnehabose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Bathinda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , , (1) ICD-10 Condition: C051||Malignant neoplasm of soft palate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional fractionation radiotherapy  5 fractions per week radiotherapy with weekly Cisplatin at 40mg/sq m 
Intervention  Radiation therapy  Radiation therapy 6 fractions per week as opposed to conventionally used 5 fractions per week with weekly Cisplatin at 40mg/sq m in both arms 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Biopsy proven squamous cell carcinoma of
head and neck.

Patients who did not receive any prior
management for the malignancy like surgery,
radiotherapy or chemotherapy.

Patients having malignancy in nasopharynx,
oropharynx, hypopharynx and larynx amongst
the subsites of head and neck.

Patients with malignancy of aforementioned
sites of Stage II, III, IV A and IV B

Patients’ performance status should be less
than or equal to 2 according to ECOG.

Patients who are willing to provide written
informed consent. 
 
ExclusionCriteria 
Details  Patients less than 18yrs of age or more than equal to
70 years of age

Patients having malignancy in lips, oral cavity, nasal
cavities and paranasal sinuses.

Patients who received prior management in the form
of surgery, radiation or chemotherapy

ECOG score more than 2

Patients with metastatic disease

Patients with deranged renal function

Patients not willing to give written consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the locoregional control rates in both the arms.  To compare the locoregional control rates in both the arms at the end of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the disease-free survival rates in each arm of the study.

2. To assess and compare toxicities as well as compliance in both the arms. 		 both at 6 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 1/ Phase 2 
Date of First Enrollment (India)   26/01/2026 
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="6"
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsnehabose@gmail.com].

  6. For how long will this data be available start date provided 01-08-2026 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Study Overview and Objectives: This study compares accelerated radiotherapy with concurrent chemotherapy against conventional fractionation chemoradiotherapy in locally advanced head and neck cancers using Volumetric Modulated Arc Therapy (VMAT). The primary objective is to compare locoregional control rates, with secondary objectives including disease-free survival, toxicity assessment, and treatment compliance.

Study Design and Population: An open-label, prospective, single-centre randomized control trial conducted at AIIMS Bathinda over 6 months 

Sample Size and Randomization: Sample size was calculated as 35 patients per arm based on locoregional control rates from DAHANCA 6 and 7 trials. Two treatment arms: Arm A receives 70 Gy in 35 fractions over 6 weeks with Cisplatin 40 mg/m2; Arm B receives 70 Gy in 35 fractions over 7 weeks with the same chemotherapy regimen.

Study Flow and Follow-up: Patients provide informed consent, undergo eligibility screening, and are followed up at 1, 2, 4, and 6 months post-treatment for response evaluation at primary and regional sites, toxicity profiling, and imaging (PET CT/CECT) using RECIST criteria.

 
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