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CTRI Number  CTRI/2024/04/066503 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing efficacy and toxicity of Hypofractionated Radiotherapy and conventional radiotherapy  
Scientific Title of Study   Hypofractionated Versus Conventional Fractionated Radiotherapy with concomitant Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma- a single institutional Randomised 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  Abhishek Basu 
Designation  Associate professor 
Affiliation  Department of Radiation Oncology at Burdwan Medical College and Hospital 
Address  Department of Radiation Oncology,Burdwan Medical College, Barddhaman, West Bengal

Barddhaman
WEST BENGAL
713104
India 
Phone  9830303459  
Fax    
Email  Drabhishekbasu@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Abhishek Basu 
Designation  Associate professor 
Affiliation  Department of Radiation Oncology at Burdwan Medical College and Hospital 
Address  Department of Radiation Oncology, Burdwan Medical College, Barddhaman, West Bengal

Barddhaman
WEST BENGAL
713104
India 
Phone  9830303459  
Fax    
Email  Drabhishekbasu@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Abhishek Basu 
Designation  Associate professor 
Affiliation  Department of Radiation Oncology at Burdwan Medical College and Hospital 
Address  Department of Radiation Oncology, Burdwan Medical College, Barddhaman, West Bengal

Barddhaman
WEST BENGAL
713104
India 
Phone  9830303459  
Fax    
Email  Drabhishekbasu@yahoo.com  
 
Source of Monetary or Material Support  
not applicable 
 
Primary Sponsor  
Name  Department of Radiation Oncology 
Address  BURDWAN MEDICAL COLLEGE, BURDWAN, WEST BENGAL, PIN-713104 
Type of Sponsor  Government medical college 
 
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 
ARYAN MALHOTRA  BURDWAN MEDICAL COLLEGE  Depart of Radiation Oncology,BURDWAN MEDICAL COLLEGE, BARDDHAMAN, West Bengal, Pin code- 713104
Barddhaman
WEST BENGAL 
9355520240

aryanpnp@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BURDWAN MEDICAL COLLEGE & HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, (2) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (3) ICD-10 Condition: C140||Malignant neoplasm of pharynx, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CONVENTIONAL RADIOTHERAPY  Conventional radiotherapy (70 Gy, 35F, 5F/wk over 7 weeks) with concomitant weekly cisplatin(35mg/m2) 
Comparator Agent  HYPOFRACTIONATED RADIOTHERAPY WITH CONCOMITANT CISPLATIN  Hypofractionated radiotherapy (55 Gy, 20F, 5F/wk over 4 weeks) with concomitant weekly cisplatin(35mg/m2)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Histological and cytological proven cases of stage II- IVb Squamous cell carcinoma of the head and neck
Primary tumor sites Oropharynx, hypopharynx, larynx 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the treatment response in both the arms as per RECIST 1.1, or Response Evaluation Criteria in Solid Tumours version 1.1  During treatment patients will be examined weekly. After treatment all the patients will be followed up every month for the next 6 months and then every three months till the end of the follow-up period
Locoregional Control will be assessed 12weeks after completion of EBRT using same imaging modality used at baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the toxicity (Acute and late) in both arms using Common Terminology Criteria for Adverse Events (CTCAE v 6.0)
To assess quality of life in both the arms as per EORTC QLQ-C30 and QLQ-HN43
To assess disease free survival in both the arms
 
During treatment patients will be examined weekly. After treatment all the patients will be followed up every month for the next 6 months and then every three months till the end of the follow-up period
Locoregional Control will be assessed 12weeks after completion of EBRT using same imaging modality used at baseline
 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 2 
Date of First Enrollment (India)   08/05/2024 
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="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
In India, according to GLOBOCAN 2022, cancers of Lip and Oral Cavity are the 2nd most
prevalent. Similarly, cancer of larynx stands 13th in rank in distribution of new cases and in
death due to cancers in 2022.
Whereas, Hypopharynx, Oropharynx and Nasopharynx stand on 15th, 16th, 27th rank
respectively in distribution of new cancer cases in 2022. Death due to these cancers hold rank
20th, 17th and 25th respectively for Hypopharynx, Oropharynx and Nasopharynx. Tobacco
smoking and chewing is commonest known etiological factor.
Management of loco-regionally advanced head and neck squamous cell carcinoma with
curative intent has evolved considerably over time with active research, volumes of literature,
large randomized control trials and meta-analyses supporting evidence-based guidelines [3].
Attempts to cure such patients with aggressive multimodality treatment or intense radiotherapy
regimens have not succeeded till date. The 5-year survival even with aggressive multimodal
approach is reported to be <20%, with a median survival less than 12 months.
Strategies that modulate the biological response of tumours or normal tissues to radiation
include altered fractionation schedules, combined modality treatments using chemotherapeutic
agents and more recently biological agents targeting molecular processes and signalling
pathways. Altered fractionation schedules seek to improve the therapeutic ratio between
tumour cell kill and normal tissue damage by exploiting the dissociation between acute and
late radiation effects.There is no doubt that hypofractionation offer potential benefits to the
patients and economy of health system, but their clinical implementation should not be at the
expense of a lower likelihood of tumour control or a greater adverse effect on normal
tissue.[4][5] The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic
has developed an interest in hypofractionation radiotherapy (HFRT) in few malignancies,
including locally advanced head and neck cancer.
Furthermore, besides the evident logistical advantages, radiobiological modelling suggests that
3.0 Gy per fraction or accelerated hyperfractionation schedules (1.8 Gy per fraction with two
fractions per weekday) are considerably more effective for head and neck tumour control and
for the reduction in late effects than the standard 2Gy fractionation.
Finding a hypofractionated radiotherapy schedule along with concurrent chemotherapy with
radical intent or with the aim of a prolonged local control with equivalent toxicity as compared
to standard regimen would be significantly advantageous in this group of patients. The External
Beam Radiation most commonly given to patients with Head and Neck cancer not intervening
into any surgery is 70 Gy in 35 fractions over 7weeks. The treatment continues for at least 7
weeks. Treatment with Radiotherapy develops some acute effects like mucositis, radiation
dermatitis, xerostomia, viscous mucous production, dysphagia, dyspnoea, dysgeusia, pain due
to inflammatory reaction and the production of reactive oxygen species causing damage to
mucosa and soft tissue
The aim of this study is to identify whether Hypofractionated (55 Gy, 20F, 5F/wk. over 4
weeks) with weekly cisplatin shows similar results to Conventional (70 Gy, 35F, 5F/wk. over
7 weeks) with weekly cisplatin with respect to both loco-regional tumour control and Grade 3+
late adverse events
 
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