| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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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 |
|
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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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