Can early oral cancer patients skip neck surgery?

NCT ID NCT06623266

NEW Disease control Sponsor: Huashan Hospital Source: ClinicalTrials.gov ↗

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers compare two ways to manage the neck in people with early oral squamous cell carcinoma, a cancer that has not spread to lymph nodes. One group has surgery to remove the primary tumor only, then regular checkups with imaging to watch for lymph node spread. The other group has the primary tumor removed along with elective neck dissection, surgery to take out neck lymph nodes. The trial tracks lymph node metastasis, disease-free survival, overall survival, and quality of life over at least two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: neck observation versus elective neck dissection (surgery to remove neck lymph nodes)
What this could lead to: If neck observation proves safe, some people with early oral cancer could avoid neck surgery and its side effects. It could also spare health systems the cost of an operation that may not be needed.
What could go wrong: Watching the neck instead of operating may let cancer spread to lymph nodes before it is caught, which could mean more treatment later. The trial runs for at least two years, and it may take longer to show whether the two approaches differ in survival.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lip and oral cavity carcinoma Lymphatic Metastasis metastatic malignant neoplasm in the lymph nodes Mouth Neoplasms oral cavity squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymph node metastasis Oral cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can early oral cancer patients skip neck surgery?

What the study statuses mean