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CTRI Number  CTRI/2025/02/080046 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal Study 
Study Design  Single Arm Study 
Public Title of Study   Chemotherapy plus immunotherapy in borderline resectable oral cavity cancer. 
Scientific Title of Study   Low dose Nivolumab plus DCF(Docetaxel, Cisplatin, 5-Flourouracil) in Locally Advanced Technically Unresectable Oral Cavity Cancer – A Single Centre Study From Eastern India. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akash Amruthrao Bhange 
Designation  Senior Resident 
Affiliation  Institute of Medical sciences and SUM Hospital 
Address  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar Khordha

Khordha
ORISSA
751003
India 
Phone  9421660687  
Fax    
Email  drakashbhange@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lalatendu Moharana 
Designation  Associate Professor 
Affiliation  Institute of Medical sciences and SUM Hospital 
Address  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar Khordha

Khordha
ORISSA
751003
India 
Phone  9538752579  
Fax    
Email  drlalatendu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akash Amruthrao Bhange 
Designation  Senior Resident 
Affiliation  Institute of Medical sciences and SUM Hospital 
Address  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar Khordha

Khordha
ORISSA
751003
India 
Phone  9421660687  
Fax    
Email  drakashbhange@gmail.com  
 
Source of Monetary or Material Support  
Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan K8 Kalinga Nagar, Kalinganagar, Bhubaneswar, Odisha 751003 
 
Primary Sponsor  
Name  Department of Medical Oncology 
Address  Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar Khordha 
Type of Sponsor  Private 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 
Dr Akash Amruthrao Bhange  Institute of Medical sciences and SUM Hospital  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar Khordha
Khordha
ORISSA 		 9421660687

drakashbhange@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL Siksha O Anusandhan (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Biopsy-proven locally advanced oral cavity cancer with T4aN3b or T4bN3b
Age above 18 years
WithanEasternCooperativeOncologyGroupperformancestatusof 0-2
With normal cardiac, renal, hematologic, hepatic, and pulmonary function
 
 
ExclusionCriteria 
Details  Lesion of T4a/T4b with high ITF, base of skull and carotid sheath involvement.
Pregnant and lactating females.
Patients with uncontrolled DM/HTN
Patients with autoimmune disease.
Patients receiving immunosuppressants. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine Curative Resection Rate with DCF plus low dose nivolumab in locally advanced unresectable oral cavity cancer patients.  Every 3 monthly 
 
Secondary Outcome  
Outcome  TimePoints 
To assess Response rate with DCF plus low dose nivolumab in locally advanced unresectable oral cavity cancer.
To establish Progression Free Survival (PFS).
To determine Overall Survival Rate.
To evaluate toxicity profile.
 		 Every 3 monthly 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   17/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

This research proposal aims to evaluate the combination of low-dose Nivolumab with DCF chemotherapy (Docetaxel, Cisplatin, 5-Fluorouracil) for treating locally advanced, technically unresectable oral cavity cancers. The study seeks to determine if this combination improves curative resection rates, response rates, progression-free survival (PFS), overall survival (OS), and evaluates the toxicity profile. Given the high incidence and challenges in treating unresectable oral cancers in India, this study proposes a more accessible treatment alternative through low-dose Nivolumab, with the hope of improving patient outcomes. The study will be conducted at IMS & SUM Hospital in Bhubaneswar, India.

 

 
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