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CTRI Number  CTRI/2025/05/087805 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
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 conventional radiotherapy with short course Radiotherapy in inoperable oral cancer. 
Scientific Title of Study   Randomised comparative study between concomitant chemoradiotherapy with conventional fractionation and hypofractionation radiotherapy in unresectable locally advanced carcinoma of the oral cavity. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1320-0687  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankur Saha 
Designation  Post Graduate Trainee 
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital 
Address  Department of Radiotherapy, Institute of Post Graduate Medical Education and Research and SSKM Hospital,244, A.J.C. Bose Road, Kolkata 700 020

Kolkata
WEST BENGAL
700020
India 
Phone  9599177573  
Fax    
Email  drankursaha@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amitabha Manna 
Designation  Professor 
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital 
Address  Department of Radiotherapy, Institute of Post Graduate Medical Education and Research and SSKM Hospital,244, A.J.C. Bose Road, Kolkata 700 020

Kolkata
WEST BENGAL
700020
India 
Phone  9433009577  
Fax    
Email  amitavamanna1965@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amitabha Manna 
Designation  Professor 
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital 
Address  Department of Radiotherapy, Institute of Post Graduate Medical Education and Research and SSKM Hospital,244, A.J.C. Bose Road, Kolkata 700 020

Kolkata
WEST BENGAL
700020
India 
Phone  9433009577  
Fax    
Email  amitavamanna1965@gmail.com  
 
Source of Monetary or Material Support  
Department of Radiotherapy, IPGMER and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata 700020 
 
Primary Sponsor  
Name  Dr Ankur Saha 
Address  Department of Radiotherapy, Institute of Post Graduate Medical Education and Research and SSKM Hospital, 244, A.J.C. Bose Road, Kolkata 700 020 
Type of Sponsor  Other [Self] 
 
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 Ankur Saha  Institute of Post Graduate Medical Education and Research  Room no. 4, Department of Radiotherapy, 244, A.J.C. Bose Road, Kolkata 700020
Kolkata
WEST BENGAL 		 9599177573

drankursaha@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH RESEARCH OVERSIGHT COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Fractionation Chemoradiotherapy  Conventional fractionation radiotherapy with 70Gy in 35 fractions, 2Gy per fraction, single fraction per day, 5 fractions per week for a total of 7 weeks with concomitant chemotherapy with weekly Injections of Cisplatin 40mg/m2 .  
Intervention  Hypofractionated Radiotherapy  Hypo fractionated radiotherapy with 55Gy in 20 fractions, 2.75Gy per fraction, single fraction per day, 5 fractions per week for a total of 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All histological and/or cytological proven cases of primary malignancy of Squamous cell carcinoma of the oral cavity.
Unresectable and Locally advanced disease.
Age between 18 to 70 years, with Performance Status ECOG 0,1,2.
Previously untreated for any type of cancer.
Normal haematological parameters.
Patients willing to participate in the study with a written and informed consent. 
 
ExclusionCriteria 
Details  Previous history of Radiotherapy in Head and Neck region.
Patients with collagen vascular disease or any other systemic comorbidities or severe uncontrolled infection, which may alter treatment outcome.
Pregnant or nursing women.
Patients who had impaired liver function, bone marrow suppression & renal dysfunction.
Recurrent disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Response assessment
 		 at baseline, after completion of radiation, at 3 months, at 6 months, at 9 months, at 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Toxicities  at baseline, after completion of radiotherapy, 3 months, 6 months, 9 months, 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 
Date of First Enrollment (India)   02/06/2025 
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="1"
Months="5"
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 27-01-2027 and end date provided 27-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

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

Oral cavity cancer represents a significant subset of head and neck malignancies, encompassing tumours that arisein the lips, tongue, floor of the mouth, buccal mucosa, hard palate and gingiva. According to GLOBOCAN 2022, with 3,89,765 new cases, it is the 10th most common cancer in men and 15th most common cancer in women worldwide.In India, 1,43,759 new cases of lips and oral cavity cancers were recorded, which accounts for almost 36% of all global cases, making it a significant public health concern.The majority of patients in India present at advanced stages, limiting surgical resection options and necessitating aprimary role for radiation therapy in the curative or palliative setting. 

The proposed study is a prospective, comparative, single institute based study. A convenient sampling method shall be applied for patients diagnosed with Oral cavity squamous cell carcinoma who received prior induction chemotherapy and will be undergoing either concomitant chemo-radiotherapy with conventional fractionation or hypo fractionated radiotherapy at the Department of Radiotherapy in IPGME&R and SSKM Hospitals, Kolkata, West Bengal.

This study aims to provide a comprehensive and rigorous framework for comparing conventional fractionation and hypo fractionation in the management of inoperable oral cavity cancer, with the ultimate goal of informing evidence- based clinical practice. It is expected to compare the two arms in terms of loco regional control and Progression free survival (PFS) and also study the toxicities associated with the treatment. 

 
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