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CTRI Number  CTRI/2025/09/094097 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A study to create a tool to predict outcomes in head and neck cancer patients with extra nodal extension 
Scientific Title of Study   Development and validation of a prognostic model to predict survival in head and neck cancer patients with extranodal extension 
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 Mudit Agarwal 
Designation  Senior Consultant 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of surgical oncology , Head and Neck division
Room no.3062, Ground floor , Sector-5 Rohini
North West
DELHI
110085
India 
Phone  9901206437  
Fax    
Email  mudit1000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mudit Agarwal 
Designation  Senior Consultant 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of surgical oncology , Head and Neck division
Room no 3062, Ground floor , Rajiv Gandhi Cancer Institute and Research Centre, Sector-5 , Rohini , New Delhi
North West
DELHI
110085
India 
Phone  9901206437  
Fax    
Email  mudit1000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Mudit Agarwal 
Designation  Senior Consultant 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of surgical oncology , Head and Neck division
Room no 3062, Ground floor , Rajiv Gandhi Cancer Institute & Research Centre , Sector-5 , Rohini , New Delhi
North West
DELHI
110085
India 
Phone  9901206437  
Fax    
Email  mudit1000@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  RAJIV GANDHI CANCER HOSPITAL AND RESEARCH CENTRE 
Address  SECTOR-5 ROHINI NEW DELHI -110085 INDIA 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SMRITI PANDA  NATIONAL CANCER INSTITUTE   Department of ENT-Oncology, National Cancer Institute – All India Institute of Medical Sciences (Jhajjar Campus), Jhajjar- 124105 . Haryana, India
Jhajjar
HARYANA 		 9717827306

smriti.panda.87@gmail.com 
MUDIT AGARWAL  RAJIV GANDHI CANCER HOSPITAL AND RESEARCH CENTRE  Room no 3062, Department of surgical oncology , Head and Neck division, sector-5, ROHINI-110085
North West
DELHI 		 9901206437

mudit1000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE   Approved 
INSTITUTIONAL REVIEW BOARD   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (2) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (3) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (4) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (5) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (6) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (7) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All head and neck cancer cases of the oral cavity , oropharynx , larynx and hypopharynx with histologically confirmed extra nodal extension from two centres as mentioned earlier 
 
ExclusionCriteria 
Details  Patients with recurrent disease at presentation, distant metastases at diagnosis, or incomplete follow-up data 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify a ‘ high -risk’ cohort within the patients with extranodal extension by designing a nomogram , specifically to identify candidates who might potentially benefit from treatment escalation.  31 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="440"
Sample Size from India="440" 
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)   12/09/2025 
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="0"
Days="0" 
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 - 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
    Response -  Statistical Analysis Plan

  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 [mudit1000@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 30-09-2026?
    Response (Others) - 

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

This is a multicentric retrospective study being conducted at All India Institute of Medical Sciences  New Delhi and Rajiv Gandhi Cancer Institute & Research Centre  New Delhi. The study aims to develop and validate a prognostic model to predict survival outcomes in patients with head and neck squamous cell carcinoma who have pathological Extranodal extension.

Despite receiving standard adjuvant chemoradiotherapy, patients with extranodal extension continue to have poor prognosis with high rates of recurrence. It is unclear whether additional pathological factors such as number of positive nodes, extent of extra nodal extension, tumor subsite, higher T stage, depth of invasion, and margin status independently influence outcomes and necessitate treatment escalation.

In this study, clinicopathological data of patients with extra nodal extension will be collected from both centres. A Cox proportional hazards model will be used to construct and validate a multivariable prognostic model, with internal validation through repeated random split-sample cross-validation and bootstrapping. The expected outcome is the development of a clinically applicable nomogram to identify a high-risk subset of patients with ENE who may be candidates for future trials on treatment intensification.

The findings are anticipated to provide an evidence-based tool for risk stratification and treatment decision-making in head and neck cancer patients with extra nodal extension.

 
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