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CTRI Number  CTRI/2019/10/021487 [Registered on: 01/10/2019] Trial Registered Prospectively
Last Modified On: 30/09/2019
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   A study comparing efficacy and toxicity between 6 fractions per week radiotherapy vs 5 fractions per week radiotherapy along with weekly chemotherapy in both cases in locally advanced inoperable head and neck squamous cell cancer 
Scientific Title of Study   A randomized prospective study comparing efficacy and toxicity between concurrent accelerated chemoradiotherapy vs concurrent chemoradiotherapy in locally advanced inoperable head and neck squamous cell cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U111112408082  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pritam Kumar Sardar 
Designation  Post Graduate trainee 
Affiliation  Ipgmer sskm hospital 
Address  Room no 1 cancer block department of radiotherapy Ipgmer Sskm Hospital Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  8420850866  
Fax    
Email  pritam.ks1990@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Siddhartha Basu 
Designation  Professor and Head of the radiotherapy department  
Affiliation  Ipgmer sskm hospital 
Address  Room no 1 cancer block department of radiotherapy Ipgmer Sskm Hospital Kolkata 700020

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  lekshmishenoi450@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pritam Kumar Sardar 
Designation  Post graduate trainee 
Affiliation  Ipgmer sskm hospital 
Address  Room no 1 cancer block department of radiotherapy Ipgmer Sskm Hospital Kolkata 700020

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  pritam.ks1990@gmail.com  
 
Source of Monetary or Material Support  
Department of radiotherapy, Ipgmer Sskm hospital cancer block 244 AJC Bose road Kolkata 700020 Government of West Bengal 
 
Primary Sponsor  
Name  Department of radiotherapy Ipgmer Sskm hospital 
Address  Cancer block 244 AJC bose road kolkata 700020 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pritam Kumar Sardar  Ipgmer Sskm hospital  Room no 1 cancer block radiotherapy department 244 AJC Bose road Kolkata 700020
Kolkata
WEST BENGAL 		 8420850866

pritam.ks1990@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER RESEARCH OVERSIGHT COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Concurrent accelerated chemoradiotherapy  6 fractions per week radiation along with weekly cisplatin chemotherapy 
Comparator Agent  Concurrent chemoradiotherapy  5 fractions radiation will be given per week along with chemotherapy cisplatin 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  1. Age more than 18 yrs and below 70 years
2. Performance status: Upto ECOG-2
3. Histologically & cytologically proven SC HNC.
4. Stage: III, IV, Non-metastatic
5. Measurable & evaluable disease without any severe systematic comorbidity or uncontrolled severe haematological abnormality.
6. Given informed written consent. 
 
ExclusionCriteria 
Details  1. Age: above 70 years.
2. Performance status: poorer than ECOG>2.
3. Stage: early stage &metastatic disease
4. Histologically any other than squamous cell carcinoma.
5. Previously treated with any type of radiation or chemotherapy: No other
previous or co-existing malignancy.
6. Any severe systemic comorbidity or sever 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess responses  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess toxicity and survival  3 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 3 
Date of First Enrollment (India)   25/10/2019 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  


Approximately 50000 patients were diagnosed annually with squamous cell head and neck (HNC) in United States. Nearly 60% of this population presents with locally advanced but non-metastatic disease. Loco regional failure constitutes the predominant recurrence pattern due to accelerated repopulation of cancer cells.

In our study in standard arm, patients will receive 66 gy in 33# with weekly cisplatin @ 40 mg/meter2 in 6.5 weeks. 5 days per week schdule.

In our experimental arm we shall be giving 66 gy over 5 weeks 3 days in a 6 days per week schdule with concurrent inj cisplatin 40 mg/m^2 weekly.this study has following aims and objectives:

 To study the difference between responses in the two arms, according to RECIST V1.1, in terms of Complete Response (CR), Partial Response (PR), Progressive Disease (PD) and Stable Disease (SD) at the end of the treatment.

To study the difference between acute toxicities in the arms, with the help of RTOG radiation morbidity criteria (CTC V1.1). To assess overall survival in both arm, disease free survival (for complete responders) and progression free survival (for partial responders and stable disease).

 
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