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CTRI Number  CTRI/2024/02/062655 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   CASE SERIES 
Study Design  Other 
Public Title of Study   To evaluate effect of immunotherapy . 
Scientific Title of Study   To evaluate effect of immunotherapy on clinical parameters using PET CT Scan in patients diagnosed with metastatic or recurrent unresectable head and neck cancer-a retrospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SO-01,Version 1.0,Dated 06/Dec/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Hari 
Designation  FELLOW 
Affiliation  HCG-NCHRI Cancer Centre 
Address  Room Number 1, Ground Floor Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51 Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square Kalamna Ring Road, Nagpur

Nagpur
MAHARASHTRA
440026
India 
Phone  8197647491  
Fax    
Email  drnidhihariomfs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhi Hari 
Designation  FELLOW 
Affiliation  HCG-NCHRI Cancer Centre 
Address  Room Number 1, Ground Floor Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51 Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square Kalamna Ring Road, Nagpur

Nagpur
MAHARASHTRA
440026
India 
Phone  8197647491  
Fax    
Email  drnidhihariomfs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi Hari 
Designation  FELLOW 
Affiliation  HCG-NCHRI Cancer Centre 
Address  Room Number 1, Ground Floor Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51 Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square Kalamna Ring Road, Nagpur

Nagpur
MAHARASHTRA
440026
India 
Phone  8197647491  
Fax    
Email  drnidhihariomfs@gmail.com  
 
Source of Monetary or Material Support  
HCG NCHRI CANCER CENTRE,NAGPUR 
 
Primary Sponsor  
Name  HCG NCHRI Cancer Centre  
Address  HCG NCHRI CANCER CENTRE NAGPUR 
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 NIDHI HARI  HCG-NCHRI CANCER CENTRE,NAGPUR  Room Number 1, Ground Floor Department Of Surgical Oncology, HCG NCHRI Cancer Centre, Khasra No. 50,51 Mouja Wanjri, Bande Nawaz Nagar, Near Automative Square Kalamna Ring Road, Nagpur
Nagpur
MAHARASHTRA 
8197647491

drnidhihariomfs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCG NCHRI CANCER CENTRE INSTITUTIONAL ETHICS CIMMITTEE  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  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Recurrent and Metastatic head and neck cancer patients who received Immunotherapy from September 2022 to September 2023 
 
ExclusionCriteria 
Details  study does not have exclusion criteria 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to measure overall survival rate, duration of response and progression free survival  After starting immunotherapy, every three weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/02/2024 
Date of Study Completion (India) 20/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Head and Neck cancers accounts for the sixth most common cancer worldwide with 8  lakh new cancer cases and 4.5 lakhs deaths worldwide.50-60%patients treated for HNC have a tendency for loco-regional recurrence within 2 years and 20-30% patients develop distant metastasis.
despite the development in chemotherapy targeted radiotherapy and surgery the estimated survival of HNSCC remains approximately 50%.
For second line treatment options for patients refractory to platinum based chemotherapy cetuximab/taxanes/methotrexate has become the standard therapy with recurrent and or metastatic local disease,resulting in progression free survival of only 2-3 months with a response rate of 4-14%.
for patients who develop unresectable or metastatic recurrence systemic therapy depends upon platinum sensitivity as well as biological factord such as PDL1 receptor status .Sytemic therapy includes platinum based chemotherapy combination with or without Immune check point inhibitors.
Tumour cells assume particular characteristics that allow them to evade the immune system by activating co-inhibitory pathways ,thereby inducing immune tolerance and tumour progression 
the use of anti-PD-1/PD-L1 has shown to restore T-cell mediated anti-tumour immunity
Pembrolimuzumab and Nivolumabv have been approved for patients with metastatic,recurrent and unresectable HNSCC 

We evaluate the OVERALL RESPONSE RATE,DURATION OF RESPONSE AND PROGRESSION FREE SURVIVAL using PET-CT Scan of patients who are undergoing Immunotherapy
 
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