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Radiation-Free hope: study tests if surgery alone is enough for rare nasal cancer

NCT ID NCT07563088

Disease control Sponsor: Eye & ENT Hospital of Fudan University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether patients with a rare nasal cancer (sinonasal adenoid cystic carcinoma) can safely avoid radiation after surgery if the tumor was completely removed. About 200 patients will choose either surgery alone or surgery plus radiation, and researchers will track cancer recurrence for 3 years. The goal is to see if skipping radiation reduces side effects without increasing the chance of cancer coming back.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Participants

About 200 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2032

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.

Who is studied

Adult patients (age 18-75 years) with histologically confirmed cribriform or tubular type sinonasal adenoid cystic carcinoma, who have undergone R0 surgical resection and have disease staged as T1-T3, N0, M0 per AJCC 8th edition. Participants are recruited from the Department of Otolaryngology of approximately 16 tertiary hospitals across China, including the lead center (Eye \& ENT Hospital of Fudan University) and collaborating centers. Consecutive patients meeting eligibility criteria are invited to enroll after providing written informed consent. Treatment assignment (postoperative radiotherapy vs. observation alone) is determined by shared decision-making between the patient and the attending physician, reflecting routine clinical practice.

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: * Age ≥18 years and ≤75 years. * Histologically confirmed adenoid cystic carcinoma of cribriform or tubular type (solid type excluded) by central pathology review. * Completed radical surgical resection with postoperative pathology confirming R0 resection (negative microscopic margins). * Tumor stage T1, T2, or T3 according to AJCC 8th edition, with N0 and M0 status. * Tumor originating from the nasal cavity or paranasal sinuses (excluding primary salivary gland tumors metastatic to this region). * ECOG performance status 0 or 1. * Adequate bone marrow, liver, and kidney function within 14 days before enrollment: * Absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥90 g/L. * Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN. * Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault formula). * Willing and able to provide written informed consent. Exclusion Criteria: * Tumor stage T4, or presence of regional lymph node metastasis (N+), or distant metastasis (M1). * Postoperative pathology showing positive margins (R1 or R2). * Prior head and neck radiotherapy. * Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. * Uncontrolled serious concomitant disease (e.g., unstable angina, recent myocardial infarction, uncontrolled hypertension). * Pregnant or breastfeeding women, or women of childbearing age not using effective contraception. * Psychological, social, or geographic factors that may interfere with study compliance.

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Conditions

The condition(s) this trial relates to.

adenoid cystic carcinoma nasal cavity and paranasal sinus carcinoma paranasal sinus adenoid cystic carcinoma

As listed by the trial registrant

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

Adenoid cystic carcinoma Sinonasal carcinoma

How to take part

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  1. The places running it

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

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Eye & ENT Hospital of Fudan University

    Shanghai, China

More trials for these conditions

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