Surgery Plus Postoperative Radiotherapy for T4 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 multicenter, prospective observational cohort study of adults with T4 sinonasal adenoid cystic carcinoma who are treated with standard surgery followed by radiotherapy. Approximately 70 patients will be enrolled across six Chinese centers over 18–24 months, with no experimental interventions. The primary endpoint is 3-year progression-free survival, and secondary outcomes include overall survival, local and distant control, recurrence, treatment-related toxicity, and quality of life. Data are collected through centralized pathology review, electronic data capture, and regular monitoring, with analyses using Kaplan-Meier methods and longitudinal QoL models. The study aims to provide real-world evidence to guide patient counseling and future research.

Why it matters

Who can join: the full rules

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).

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Not yet recruiting
• Third Xiangya Hospital, Central South University
  Changsha, Hunan, China Not yet recruiting
• The First Affiliated Hospital of China Medical University
  Shenyang, Liaoning, China Not yet recruiting
• The First Affiliated Hospital of Air Force Medical University
  Xi’an, Shanxi, China Not yet recruiting
• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Not yet 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.

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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.