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Rare sinus cancer study aims to clarify treatment outcomes

NCT ID NCT07652489

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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This status has not been confirmed recently, so it may be out of date.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 follows people with a rare and advanced cancer of the nasal cavity and sinuses called T4 sinonasal adenoid cystic carcinoma. All participants receive the standard treatment: surgery followed by radiation therapy. The goal is to measure how long people live without the cancer growing or spreading, and to track side effects and quality of life. The results will help doctors better counsel patients and design future research.

What this could mean

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

What this could lead to
If successful, this study could provide clearer survival expectations and guide treatment decisions for people with this rare cancer.
What could go wrong
This is an observational study, not a test of a new treatment. It cannot prove that surgery plus radiotherapy works better than other approaches.

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 70 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

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

This study population consists of adults (aged 18-80 years) with newly diagnosed, histologically confirmed T4 stage sinonasal adenoid cystic carcinoma (SNACC) according to AJCC 8th edition. Eligible patients have ECOG PS 0-2, adequate organ function, and are deemed resectable by multidisciplinary team evaluation. Both M0 and selected M1 patients (with stable limited lung metastases) are included. Patients with other active malignancies, severe uncontrolled comorbidities, prior anticancer treatment, or unresectable disease (e.g., bilateral cavernous sinus involvement) are excluded. The study aims to enroll approximately 70 participants from six tertiary referral centers in China.

Ages

18 to 80 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: 1. Age 18 80 years, any gender; ECOG performance status 0 2; life expectancy ≥6 months. 2. Histologically confirmed primary sinonasal adenoid cystic carcinoma (cribriform, tubular, solid, or mixed type). Other malignancies excluded. 3. T4 stage (T4a or T4b) according to AJCC 8th edition, based on contrast enhanced MRI/CT. 4. N0 2 (operable lymph node metastasis allowed). 5. M0 (no distant metastasis on chest CT and abdominal ultrasound) OR M1 with stable limited lung metastases; (c) stable on two CT scans ≥3 months apart; (d) no respiratory symptoms. 6. Previously untreated (no radiotherapy, chemotherapy, targeted therapy, immunotherapy, or tumor resection). MDT deems technically resectable (R0/R1 achievable, not diffusely unresectable). 7. Adequate organ function within 14 days before enrollment: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, Hb ≥90 g/L; ALT/AST ≤2.5×ULN, TBil ≤1.5×ULN, Cr ≤1.5×ULN or CrCl ≥50 mL/min; LVEF ≥50%, no uncontrolled arrhythmia. 8. Willing and able to provide written informed consent for clinical data collection (and optional biospecimen banking). Investigator judges good compliance. Exclusion Criteria: 1. Progressive lung metastases within 6 months (new lesions or \>20% increase); extrapulmonary metastases (liver, bone, brain); symptomatic lung metastases. 2. MDT judged unresectable, e.g., bilateral cavernous sinus invasion, brain parenchyma invasion, bilateral internal carotid artery encasement. 3. Primary tumor outside sinonasal cavity (e.g., major salivary glands, oropharynx); non ACC histology. 4. Other active malignancy within 5 years (except cured basal cell carcinoma, cervical carcinoma in situ, etc.). 5. Severe comorbidities: NYHA class III/IV heart failure, recent myocardial infarction or unstable angina, uncontrolled hypertension (≥160/100 mmHg); COPD requiring home oxygen or interstitial lung disease; decompensated cirrhosis; active hepatitis B/C without antiviral therapy; nephropathy requiring dialysis; active serious infection; active bleeding or coagulopathy (INR \>1.5×ULN without anticoagulation, or platelets \<50×10⁹/L). 6. Special populations: pregnant or breastfeeding; unwilling to use contraception (if childbearing potential); severe allergy to medications required for surgery/radiotherapy; severe psychiatric or cognitive disorder impairing cooperation; currently participating in another interventional trial. 7. Unable to undergo contrast enhanced MRI (metal implants, claustrophobia, gadolinium allergy); investigator judges inability to complete follow up (e.g., living abroad, substance abuse).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 sites. 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

    RECRUITING

    Shanghai, Shanghai Municipality, 200031, China

  • The First Affiliated Hospital of Air Force Medical University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710032, China

  • The First Affiliated Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • The First Affiliated Hospital of Wenzhou Medical University

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The Second Affiliated Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150001, China

  • Third Xiangya Hospital, Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, 410013, China

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