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CTRI Number  CTRI/2013/04/003568 [Registered on: 17/04/2013] Trial Registered Retrospectively
Last Modified On: 18/04/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   NECK DISSECTION VERSUS OBSERVATION IN EARLY ORAL CAVITY CANCER 
Scientific Title of Study   ELECTIVE VERSUS THERAPEUTIC NECK DISSECTION IN THE TREATMENT OF EARLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY 
Trial Acronym  N0 Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT00193765  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil K Dcruz 
Designation  MS., DNB, FRCS (HON) 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax    
Email  docdcruz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil K Dcruz 
Designation  MS., DNB, FRCS (HON) 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax    
Email  docdcruz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil K Dcruz 
Designation  MS., DNB, FRCS (HON) 
Affiliation  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax    
Email  docdcruz@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil K D cruz  Tata Memorial Hospital  CRS dept, annex bldg, 5 th floor, Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India
Mumbai
MAHARASHTRA 
022-24177000

docdcruz@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  T1, T2 oral cavity cancer with node negative neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Early oral cancer Node negative neck   Elective Vs Therapeutic neck dissection in early oral cancer Elective neck dissection in early node negative oral cancers 
Intervention  surgery/anaesthesia  Procedure: Elective Vs Therapeutic neck dissection in early oral cancer 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
2. Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
3. No history of a prior malignancy in the head and neck region.
4. No prior malignancy outside the head and neck region in the preceding 5 years.
5. Patient will be reliable for follow-up
6. Age> 18 years and < 75 years.
7. No significant co-morbid conditions - ASA grade II and I.
8. Understands the protocol and is able to give informed consent.
 
 
ExclusionCriteria 
Details  . Prior radiotherapy or surgery for malignancy in the head and neck region.
2. Non squamous cell carcinomas of the oral cavity.
3. Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
4. Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
5. Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e. therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.  overall survival 
 
Secondary Outcome  
Outcome  TimePoints 
Does USG examination have any role in routine initial workup of node negative patient? How are patients followed up –does USG have role or clinical examination sufficient. Is assessment of tumor thickness by surgeon at time of initial surgery accurate –Is there correlation between tumor thickness as measured grossly by surgeon, at FS versus final HPR. Identify HPR prognostic factors in primary that may help identify sub-set of patients at increased risk of cervical metastasis.  5 years 
 
Target Sample Size   Total Sample Size="710"
Sample Size from India="710" 
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)   07/01/2004 
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="11"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cervical metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable.

There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.

Primary objective:

To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e. therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.

Secondary Objective:

1. Does Ultrasound examination have any role in the routine initial workup of a node negative patient? 2. How are patients ideally followed up –does sonography have a role or is clinical examination sufficient. 3. Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate –Is there a correlation between tumor thickness as measured grossly by the surgeon, at frozen section versus final histopathology. 4. Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk of cervical metastasis.

 

 
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