Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06623266

Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

Led by Huashan Hospital · Updated on 2024-11-14

300

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only.

CONDITIONS

Official Title

Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Tumor located in tongue, gingiva, buccal mucosa, floor of mouth, hard palate, or retromolar area
  • Clinical stage is cT1N0M0 according to AJCC 8th edition
  • Pathological diagnosis of squamous cell carcinoma
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • More than 2 lesions in the oral cavity
  • History of malignant tumor within the past 5 years unless fully treated and no recurrence
  • Previous unilateral or bilateral neck dissection
  • Prior head and neck radiotherapy
  • Pregnant or lactating women
  • Severe uncontrolled infection, known HIV infection, or history of organ, stem cell, or bone marrow transplant
  • Participation in another clinical study within 30 days before enrollment
  • Other conditions deemed unsuitable by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huashan Hospital, Fudan University

Shanghai, China, 200040

Actively Recruiting

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Research Team

L

Lai-ping Zhong, MD, PhD

CONTACT

L

Liang Gu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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