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CTRI Number  CTRI/2025/02/080494 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Surgical Techniques for Tongue Cancer: A Randomised Study on Outcomes in intermediate Cases. 
Scientific Title of Study   Surgical Outcomes in Compartmental Glossectomy and Standard Wide Margin Excision in T2-T3 Oral Tongue Squamous Cell Carcinoma- A Randomised Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Roshan Ali C H 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of otorhinolaryngology, head and neck surgery 4th Floor, Teaching Block, AIIMS, Ansari Nagar, New Delhi- 110029

New Delhi
DELHI
110029
India 
Phone  7005702674  
Fax    
Email  aliroshanch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Roshan Ali C H 
Designation  Senior Resident 
Affiliation  AIIMS, NEW DELHI 
Address  Department of otorhinolaryngology, head and neck surgery 4th Floor, Teaching Block, AIIMS, Ansari Nagar, New Delhi- 110029

New Delhi
DELHI
110029
India 
Phone  7005702674  
Fax    
Email  aliroshanch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Roshan AliI C H 
Designation  Senior Resident 
Affiliation  AIIMS, NEW DELHI 
Address  Department of otorhinolaryngology, head and neck surgery 4th Floor, Teaching Block, AIIMS, Ansari Nagar, New Delhi- 110029

New Delhi
DELHI
110029
India 
Phone  7005702674  
Fax    
Email  aliroshanch@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [No Sponsor] 
 
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 
Roshan Ali C H  All India Institute of Medical Sciences, New Delhi  Dept of ENT,4th Floor, Teaching Block, AIIMS, Ansari Nagar, New Delhi- 110029
New Delhi
DELHI 
7005702674

aliroshanch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, AIIMS, NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (3) ICD-10 Condition: C02||Malignant neoplasm of other and unspecified parts of tongue, (4) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Compartmental glossectomy  First arm- T2-T3 Tongue carcinoma cases will undergo compartmental glossectomy as per randomisation. 
Comparator Agent  Standard wide margin excision  Second arm- T2-T3 Tongue carcinoma cases will undergo Standard wide margin excision as per randomisation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  (a) AJCC 8th edition cT2 and cT3 Tongue cancers
(b) Primary head and neck squamous cell cancers
(c) CTS and SWMS with or without extension to adjacent oropharyngeal subsites (ipsilateral palatine tonsil and/or base of tongue). 
 
ExclusionCriteria 
Details  (a) AJCC 8th edition cT1 and cT4Tongue cancers
(b) Lesion reaching midline or crossing midline
(c) Patient with distant metastasis (M1)
(d) All previously treated, recurrent or residual cases of OTSCC
(f) All patients who have taken Neoadjuvant chemotherapy (NACT) or Interstitial brachytherapy(IBRT)
(f)Not willing to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the deep margin between compartmental glossectomy and standard wide margin surgery.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare speech outcomes between compartmental glossectomy and standard wide margin surgery using London speech evaluation scale.
2. To compare swallow outcomes between compartmental glossectomy and standard wide margin surgery using Functional Oral Intake Scale. 
2 years 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/02/2025 
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)   Not Applicable 
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  

Oral squamous cell carcinoma (OSCC) represents the 16th most common neoplasm worldwide, with almost 389846 new cases/year and over 188 438 deaths, as estimated in GLOBOCAN-2022. The most frequent OSCC subsite involved is the mobile oral tongue (OT) and an increasing incidence has been observed among people aged <45 years in the last decades.

According to GLOBOCAN, in 2022, the estimated incidence rate for men was 14.7 per 100000, while for women in India, it was 5.0. For men, India, oral cancer is the major cancer, while for women, oral cancer is the fourth major cancer after breast, cervix and ovary. Oral tongue being the second most common subsite in OSCC.

Surgery represents the first-choice treatment for OTSCC, even though a reliable and standardized procedure has not been universally recognized so far.

The gold standard for stages I-II OTSCC is transoral surgical excision with elective neck dissection if the pathological depth of invasion (DOI) is more than 4 and up to 9 mm.  Stages III-IV OTSCC, with a DOI ≥10 mm, should be managed by “en-bloc” tumor removal and concomitant neck dissection carrying out a so called standard wide margins surgery (SWMS) or, alternatively, a compartmental surgery (CTS) approach. SWMS is performed removing the tumor with clinically disease-free margins (variably defined as in between 1 and 2 cm), not considering the anatomical structures or preferential tumor cell spreading pathways. On the other side, the principles of CTS as proposed by Calabrese et al. in 2011 described a compartmental tongue resection technique (CTS) where the muscular (mylohyoid), neurovascular (lingual nerve and vein), and glandular (sublingual and submandibular) tissues within the compartment, that form a bridge between the primary tumor and the cervical lymphatic chain will be removed as a single compartment.

A transoral glossectomy with discontinuous neck dissection seems to be the current surgical practice for patients who have oral tongue cancer. There have been arguments about whether to remove the intervening tissues between the primary site and the neck. It is apparent that the lymphatic drainage from the oral tongue travels through the floor of the mouth before entering the upper neck, and some recurrences develop in this area.

In CTS, the extrinsic muscles of the tongue, even though partially infiltrated by the neoplasm, are completely dissected from their bony insertions and the concept of “en-bloc” removal is extended to all anatomical structures and stromal tissues connecting the primary to the cervical lymph nodes identified as the “T-N tract.”  A comprehensive clearance of the T-N tract represents the main difference with the SWMS, in which the continuity with cervical lymph nodes is obtained only by dissecting the sublingual area. The first study by Calabrese et al. reported that CTS ensured a better local, loco-regional disease control, overall, and disease-free survivals compared with SWMS.

This study aims to  evaluate the margin status in T2-T3 OTSCC patients treated either by CTS or SWMS. 


 
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