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

NCT07652489 | Recruiting DMC

• 1 other identifier: 2026134
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Adenoid Cystic Carcinoma; Sinonasal Carcinoma

Keywords

Carcinoma, Adenoid Cystic, Sinonasal, Radiotherapy, Adjuvant, Prospective Studies, Observational Study, Progression-Free Survival

Outcome Measures

Primary Outcomes (1)

• 3-Year Progression-Free Survival

  Time from enrollment to first documented local recurrence, regional recurrence, distant metastasis, or death. Assessed by contrast-enhanced MRI every 3-6 months; recurrence confirmed by pathology or MDT. 3-year rate estimated by Kaplan-Meier with 95% CI. Participants without event censored at last follow-up.

  Up to 3 years after enrollment

Secondary Outcomes (6)

• R0 Resection Rate

  At time of surgery (postoperative pathological assessment)

• 3-Year Overall Survival

  Up to 3 years after enrollment

• 3-Year Distant Metastasis-Free Survival

  Up to 3 years after enrollment

• 3-Year Local Control Rate

  Up to 3 years after enrollment

• Postoperative Complication Rate (CTCAE Grade ≥3)

  Within 30 days after surgery

Study Arms (1)

T4 Sinonasal Adenoid Cystic Carcinoma: Surgery plus Postoperative Radiotherapy

This single cohort includes patients with previously untreated T4 stage sinonasal adenoid cystic carcinoma (T4a or T4b, any N, M0 or M1 with stable limited lung metastases). All participants receive standard treatment as per routine clinical practice: radical surgery (aiming for R0/R1 resection, via endoscopic, open, or combined approach) followed by postoperative intensity-modulated radiotherapy (IMRT) starting within 4-6 weeks after surgery. No experimental intervention is assigned. The cohort is followed prospectively for 3 years to assess progression-free survival, overall survival, local control, distant metastasis, treatment-related complications, and quality of life.

Procedure: Surgery

Interventions

Surgery PROCEDURE

Postoperative Radiotherapy

T4 Sinonasal Adenoid Cystic Carcinoma: Surgery plus Postoperative Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age 18 80 years, any gender; ECOG performance status 0 2; life expectancy ≥6 months.
• Histologically confirmed primary sinonasal adenoid cystic carcinoma (cribriform, tubular, solid, or mixed type). Other malignancies excluded.
• T4 stage (T4a or T4b) according to AJCC 8th edition, based on contrast enhanced MRI/CT.
• N0 2 (operable lymph node metastasis allowed).
• 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.
• Previously untreated (no radiotherapy, chemotherapy, targeted therapy, immunotherapy, or tumor resection). MDT deems technically resectable (R0/R1 achievable, not diffusely unresectable).
• 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.
• Willing and able to provide written informed consent for clinical data collection (and optional biospecimen banking). Investigator judges good compliance.

You may not qualify if:

• Progressive lung metastases within 6 months (new lesions or \>20% increase); extrapulmonary metastases (liver, bone, brain); symptomatic lung metastases.
• MDT judged unresectable, e.g., bilateral cavernous sinus invasion, brain parenchyma invasion, bilateral internal carotid artery encasement.
• Primary tumor outside sinonasal cavity (e.g., major salivary glands, oropharynx); non ACC histology.
• Other active malignancy within 5 years (except cured basal cell carcinoma, cervical carcinoma in situ, etc.).
• 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).
• 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.
• Unable to undergo contrast enhanced MRI (metal implants, claustrophobia, gadolinium allergy); investigator judges inability to complete follow up (e.g., living abroad, substance abuse).

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (6)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

Third Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710032, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

Related Publications (9)

• Jang 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 RESULT

• Lee 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 RESULT

• Song 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 RESULT

• Mays 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 RESULT

• Cavalieri 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 RESULT

• Seok 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 RESULT

• Mavrikios 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.

  PMID: 37097003 RESULT

• Bjorndal K, Krogdahl A, Therkildsen MH, Overgaard J, Johansen J, Kristensen CA, Homoe P, Sorensen CH, Andersen E, Bundgaard T, Primdahl H, Lambertsen K, Andersen LJ, Godballe C. Salivary gland carcinoma in Denmark 1990-2005: a national study of incidence, site and histology. Results of the Danish Head and Neck Cancer Group (DAHANCA). Oral Oncol. 2011 Jul;47(7):677-82. doi: 10.1016/j.oraloncology.2011.04.020. Epub 2011 May 25.

  PMID: 21612974 RESULT

• Dodd RL, Slevin NJ. Salivary gland adenoid cystic carcinoma: a review of chemotherapy and molecular therapies. Oral Oncol. 2006 Sep;42(8):759-69. doi: 10.1016/j.oraloncology.2006.01.001. Epub 2006 Jun 6.

  PMID: 16757203 RESULT

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Carcinoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Quan Liu, MD

CONTACT

+86 15001959681; liuqent@163.com

Wanpeng Li, MD

CONTACT

+86 13262856870; 18879117831@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)