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临床试验/CTRI/2025/02/080494
CTRI/2025/02/080494尚未招募2/3 期

Surgical Outcomes in Compartmental Glossectomy and Standard Wide Margin Excision in T2-T3 Oral Tongue Squamous Cell Carcinoma- A Randomised Control Trial

未提供1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2025年2月22日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
122
试验地点
1
主要终点
To compare the deep margin between compartmental glossectomy and standard wide margin surgery.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • (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).

排除标准

  • (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.

结局指标

主要结局

To compare the deep margin between compartmental glossectomy and standard wide margin surgery.

时间窗: 2 years

次要结局

  • 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.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Roshan Ali C H

AIIMS, New Delhi

研究点 (1)

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