NCT07652489 Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma: A Prospective Observational Study
| NCT ID | NCT07652489 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Adenoid Cystic Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2031-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2026-06-01 with a primary completion date of 2031-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07652489 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Adenoid Cystic Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07652489 currently recruiting?
Yes, NCT07652489 is actively recruiting participants. Contact the research team at liuqent@163.com for enrollment information.
Where is the NCT07652489 trial being conducted?
This trial is being conducted at Harbin, China, Changsha, China, Shenyang, China, Shanghai, China and 2 additional locations.
Who is sponsoring the NCT07652489 clinical trial?
NCT07652489 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 70 participants.