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临床试验/CTRI/2024/10/075043
CTRI/2024/10/075043招募中不适用

Incidence of contralateral neck node metastasis in locally advanced, resectable, lateralized oral squamous cell carcinoma—a prospective interventional study

Dr.Jino JL1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
104
试验地点
1
主要终点
Incidence of contralateral nodal metastasis in histopathological specimen

研究概览

简要总结

The incidence of contralateral lymph node metastasis in lateralized oral cancer varies from 0.9% to 36% in previous studies. However, in those studies, the data is heterogeneous; most of those studies have included patients with midline disease, and many have included cases which have received treatment for the contralateral neck. No conclusions have been derived which could change management guidelines, except for identification of selected risk factors for contralateral neck metastases, like tumor stage, grade, ipsilateral neck metastases and extranodal extension.  In this study, we propose to perform contralateral elective, superselective neck dissection of levels 1b and 2a for patients with locally advanced, resectable, lateralized OSCC not crossing the midline. We aim to study the incidence of contralateral lymph node metastases and to correlate this to other clinicopathological adverse prognostic factors of OSCC. We hope to develop statistical models encompassing the factors predictive for occurrence of such metastases and to form a rational basis for elective contralateral neck management.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Resectable, locally advanced oral SCC (AJCC 8th Edition TNM Stage IVA and IVB), which does not involve or cross the midline—clinical tumor stage T4a or T4b disease in the gingivobuccal complex and T3 tumors of the tongue and floor of the mouth.
  • Ipsilateral nodal involvement with extra-nodal extension (N3b) 3) Biopsy: Poorly differentiated tumor grade 4) No clinical or radiological evidence of contralateral nodal metastasis.

排除标准

  • Past history of treatment for head and neck cancer 2) Borderline resectable, unresectable, inoperable or metastatic disease at presentation 3) Clinical or radiological evidence of contralateral nodal metastasis 4) Recurrent oral cancer planned for salvage surgery 5) Tumor involving or crossing the midline 6) T1, T2 disease 7) Multiple or synchronous primary tumors in the head and neck 8) Under 18 years of age or over 90 years of age, or who are pregnant or otherwise vulnerable.

结局指标

主要结局

Incidence of contralateral nodal metastasis in histopathological specimen

时间窗: Post surgery, second week - when the histopathological report comes, Post surgery follow-up at 3months, 6months. 9 months and one year

次要结局

  • 1)To correlate the incidence of contralateral nodal metastasis with other clinicopathological adverse prognostic factors in oral squamous cell carcinoma.
  • Contralateral nodal recurrence rate(one year)

研究者

发起方
Dr.Jino JL
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jino JL

Christian Medical College and Hospital, Vellore

研究点 (1)

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