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CTRI Number  CTRI/2013/07/003855 [Registered on: 31/07/2013] Trial Registered Retrospectively
Last Modified On: 24/07/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   RETROSPECTIVE STUDY 
Study Design  Other 
Public Title of Study   Epidemiological, Clinical and Histopathological prognostic factors in Advanced Oral Squamous Cell Carcinoma treated with Surgery followed by Radiotherapy: A Retrospective Observational study 
Scientific Title of Study   Epidemiological, Clinical and Histopathological prognostic factors in Advanced Oral Squamous Cell Carcinoma treated with Surgery followed by Radiotherapy: A Retrospective Observational study 
Trial Acronym  OSCC 
Secondary IDs if Any  
Secondary ID  Identifier 
OSCC001 VERSION 1.2 DATED 20th MARCH 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ABIDA PARVEEN 
Designation  CLINICAL RESEARCH TRAINEE 
Affiliation  MAX SUPERSPECIALTY HOSPITAL 
Address  CLINICAL RESEARCH DEPARTMENT MAX SUPERSPECIALTY HOSPITAL 2 PRESS ENCLAVE ROAD NEW DELHI 11017
DEPARTMENT OF ONCOLOGY 2 PRESS MAX SUPER SPECIALTY HOSPITAL PRESS ENCLAVE ROAD SAKET NEW DELHI 110017
New Delhi
DELHI
10017
India 
Phone  9891478449  
Fax    
Email  abida_nd62@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR HARIT CHATURVEDI 
Designation  CHAIRMAN MAX INSTITUTE OF ONCOLOGY CHIEF CONSULTANT DIRECTOR SURGICAL ONCOLOGY 
Affiliation  MAX SUPERSPECIALTY HOSPITAL 
Address  CLINICAL RESEARCH DEPARTMENT MAX SUPERSPECIALTY HOSPITAL 2 PRESS ENCLAVE ROAD NEW DELHI 11017
DEPARTMENT OF ONCOLOGY 2 PRESS MAX SUPER SPECIALTY HOSPITAL PRESS ENCLAVE ROAD SAKET NEW DELHI 110017
New Delhi
DELHI
10017
India 
Phone  9810008781  
Fax    
Email  harit.chaturvedi@maxhealthcare.com  
 
Details of Contact Person
Public Query  
Name  ABIDA PARVEEN 
Designation  CLINICAL RESEARCH TRAINEE 
Affiliation  MAX SUPERSPECIALTY HOSPITAL 
Address  CLINICAL RESEARCH DEPARTMENT MAX SUPERSPECIALTY HOSPITAL 2 PRESS ENCLAVE ROAD NEW DELHI 11017
DEPARTMENT OF ONCOLOGY 2 PRESS MAX SUPER SPECIALTY HOSPITAL PRESS ENCLAVE ROAD SAKET NEW DELHI 110017
New Delhi
DELHI
10017
India 
Phone  9891478449  
Fax    
Email  abida_nd62@hotmail.com  
 
Source of Monetary or Material Support  
MAX SUPERSPECIALTY HOSPITAL 
 
Primary Sponsor  
Name  MAX SUPERSPECIALTY HOSPITAL 
Address  MAX SUPERSPECIALTY HOSPITAL PRESS ENCLAVE ROAD SAKET NEW DELHI 110017 
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 HARIT CHATURVEDI  MAX SUPERSPECIALTY HOSPITAL  MAX SUPERSPECIALTY HOSPITAL 2 PRESS ENCLAVE ROAD NEW DELHI 110017
New Delhi
DELHI 		 9810008781

harit.chaturvedi@maxhealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE MAX SUPERSPECIALTY HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS OF ADVANCED ORAL SQUAMOUS CELL CARCINOMA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  . Patients of any age.
. Sex: both males and females
. Histological biopsy confirming Squamous Cell Carcinoma of the Oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retro molar region)
. Clinical stage III/IVA (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2006) with resectable lesions.
• Adequate hematologic function: white blood cell >3,000/mm3, hemoglobin>8g/L, platelet count>80,000/mm3.
 
 
ExclusionCriteria 
Details  . Patients with distant metastatic disease and other cancers
• Previous radiotherapy, surgery or chemotherapy done other than Max
• Other previous malignancies within last 5 years
• Another histological type of tumour or a tumour not involving the oral cavity,
• Recurrent tumour after previous treatment.
• Patients with inadequate follow-up
• Patients who have undergone for initial RT
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To determine the stage and size of the tumor
• To assess the kind of the surgical technique and the technique of the radiation used
• To determine the tumor histology grade depth of invasion presence of LVI and PNI bone invasion tumour differentiation types of surgical margins on the specimen and resection margin
• To determine the regional node size site and number of lymph nodes invaded lymph node sectors invaded presence of extracapsular extention and distant metastasis
 		 from Feb 2009 to Sep 2012 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate the early effect of age gender tobacco chewing smoking alcohol consumption dental hygiene and presence of the comorbidities on the prognosis of the disease  from Feb 2009 to Sep 2012 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   06/02/2013 
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="3"
Months="7"
Days="29" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   After the completion of this study, we intend to immediately publish the results in international and national journals. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The primary purpose for conducting this study is to evaluate the effect of various prognostic factors on the treatment response (surgery, radiotherapy and chemotherapy), recurrence status, survival duration and loco regional control in advanced oral squamous cell carcinoma patients.
 

 
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