Comparing neck observation and elective neck dissection for early-stage oral cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the outcomes of two different approaches for managing the neck in patients with early-stage oral squamous cell carcinoma (OSCC). Participants will undergo surgical resection of the primary tumor, with one group receiving elective neck dissection and the other group receiving neck observation. The study aims to assess the rates of lymph node metastasis, disease-free survival, overall survival, and quality of life over a two-year period. A total of 300 patients will be recruited for this trial, with equal distribution between the two treatment arms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara
* Clinical stage is cT1N0M0 (AJCC 8th edition)
* Pathological diagnosis of squamous cell carcinoma
* Sign the informed consent form

Exclusion Criteria:

* More than 2 lesions found in the oral cavity
* Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment)
* History of unilateral or bilateral neck dissection in the past
* History of previous head and neck radiotherapy
* Pregnant or lactating women
* Severe, uncontrolled infection or known HIV infection; or previous organ transplantation, stem cell or bone marrow transplantation
* Participated in other clinical studies within 30 days before enrollment
* Other circumstances that the researcher considers unsuitable for participation in the study

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Lai-ping Zhong, MD, PhD — Huashan Hospital
• Study coordinator: Lai-ping Zhong, MD, PhD
• Email: zhonglp@hotmail.com
• Phone: +862152888915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.