Surgery Alone or with Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma

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 is a prospective, multicenter observational study conducted in about 16 hospitals in China. Patients who had complete surgical removal (R0) of T1–T3, N0M0 sinonasal ACC are enrolled and treated according to standard care chosen by their doctor and themselves, either observation or postoperative radiotherapy. The radiotherapy arm uses IMRT or VMAT at specified doses starting within 4–6 weeks after surgery, with all participants receiving a uniform follow-up schedule. The primary aim is to determine if observation is non-inferior to radiotherapy for 3-year disease-free survival. The study will enroll around 200 patients, with analysis focusing on cancer-free outcomes and safety in real-world practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Quan Liu, MD
• Email: liuqent@163.com
• Phone: +86 15001959681

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma

  This study tests how well patients with T4 sinonasal adenoid cystic carcinoma tolerate the standard treatment of surgery followed by postoperative radiotherapy and what their 3-year progression-free survival looks like.

  Recruiting Eye & ENT Hospital of Fudan University · Harbin, Heilongjiang and 5 other locations · NCT07652489

• Becotatug vedotin plus epirubicin before surgery for EGFR-positive unresectable recurrent sinonasal adenoid cystic carcinoma

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  Recruiting Phase 2 Eye & ENT Hospital of Fudan University · Shanghai · NCT07522879

• Epirubicin chemoembolization to shrink sinonasal adenoid cystic carcinoma

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  Recruiting Phase 2 Eye & ENT Hospital of Fudan University · Shanghai, Xuhui Strict · NCT07320508

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  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07667400

• Neoadjuvant therapy with anlotinib and epirubicin for T4 sinonasal adenoid cystic carcinoma

  This trial tests whether giving a targeted drug (anlotinib) plus chemotherapy (epirubicin) before surgery helps patients with advanced sinonasal adenoid cystic carcinoma see better outcomes.

  Recruiting Phase 2 Eye & ENT Hospital of Fudan University · Beijing, Beijing Municipality and 4 other locations · NCT07616141

• Puxitatug Samrotecan (P‑Sam) for advanced, recurrent, or metastatic aggressive ACC‑I

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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.