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

Sponsor
Eye & ENT Hospital of Fudan University
Study ID
NCT07652489
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgery — PROCEDURE
    Postoperative Radiotherapy

Study Details

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.

Key Dates

First listed
Jun 17, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2031
Completion
Jun 1, 2031

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

3-Year Progression-Free Survival [ Time Frame: Up to 3 years after enrollment ]

Central Contacts

Related Studies