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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.).

Trial design

Treatments tested in this trial

  • Surgery

Treatment groups

70 Participants
are divided into 1 treatment group