Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma: A Prospective Observational Study

This observational study follows patients with T4 stage sinonasal adenoid cystic carcinoma (a rare cancer of the nasal cavity/sinuses) who receive standard treatment: surgery followed by postoperative radiotherapy. The main goal is to measure the 3-year progression-free survival rate (the percentage of patients alive without cancer growth or spread). We will also assess overall survival, recurrence, side effects, and quality of life. This multicenter, prospective study will provide much-needed real-world data to improve patient counseling and guide future research.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

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).

• RESULTJang S, Patel PN, Kimple RJ, McCulloch TM. Clinical Outcomes and Prognostic Factors of Adenoid Cystic Carcinoma of the Head and Neck. Anticancer Res. 2017 Jun;37(6):3045-3052. doi: 10.21873/anticanres.11659. PMID 28551643
• RESULTLee TH, Kim K, Oh D, Yang K, Jeong HS, Chung MK, Ahn YC. Clinical Outcomes in Adenoid Cystic Carcinoma of the Nasal Cavity and Paranasal Sinus: A Comparative Analysis of Treatment Modalities. Cancers (Basel). 2024 Mar 21;16(6):1235. doi: 10.3390/cancers16061235. PMID 38539566
• RESULTSong X, Sun J, Yang G, Wang X, Wang L. Long-term outcomes of platinum-based chemotherapy for T4 stage sinonasal adenoid cystic carcinoma. Front Pharmacol. 2025 Sep 29;16:1623242. doi: 10.3389/fphar.2025.1623242. eCollection 2025. PMID 41089828
• RESULTMays AC, Hanna EY, Ferrarotto R, Phan J, Bell D, Silver N, Mulcahy CF, Roberts D, Abdelmeguid ASA, Fuller CD, Frank SJ, Raza SM, Kupferman ME, DeMonte F, Su SY. Prognostic factors and survival in adenoid cystic carcinoma of the sinonasal cavity. Head Neck. 2018 Dec;40(12):2596-2605. doi: 10.1002/hed.25335. Epub 2018 Nov 17. PMID 30447126
• RESULTCavalieri S, Mariani L, Vander Poorten V, Van Breda L, Cau MC, Lo Vullo S, Alfieri S, Resteghini C, Bergamini C, Orlandi E, Calareso G, Clement P, Hauben E, Platini F, Bossi P, Licitra L, Locati LD. Prognostic nomogram in patients with metastatic adenoid cystic carcinoma of the salivary glands. Eur J Cancer. 2020 Sep;136:35-42. doi: 10.1016/j.ejca.2020.05.013. Epub 2020 Jul 3. PMID 32629365
• RESULTSeok J, Lee DY, Kim WS, Jeong WJ, Chung EJ, Jung YH, Kwon SK, Kwon TK, Sung MW, Ahn SH. Lung metastasis in adenoid cystic carcinoma of the head and neck. Head Neck. 2019 Nov;41(11):3976-3983. doi: 10.1002/hed.25942. Epub 2019 Aug 29. PMID 31463986
• RESULTMavrikios A, Goudjil F, Beddok A, Zefkili S, Bolle S, Feuvret L, Le Tourneau C, Choussy O, Sauvaget E, Herman P, Dendale R, Calugaru V. Proton therapy and/or helical tomotherapy for locally advanced sinonasal skull base adenoid cystic carcinoma: Focus on experience of the Institut Curie and review of literature. Head Neck. 2023 Jul;45(7):1619-1631. doi: 10.1002/hed.27371. Epub 2023 Apr 25.