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.
This is a prospective, multicenter, observational cohort study of T4 stage sinonasal adenoid cystic carcinoma (SNACC) patients receiving standard treatment (surgery followed by postoperative intensity-modulated radiotherapy). No experimental intervention is assigned. Approximately 70 patients will be enrolled from six Chinese centers over 18-24 months. Key exclusions include unresectable disease (e.g., bilateral cavernous sinus or carotid artery involvement) and progressive lung metastases. Endpoints: Primary is 3-year progression-free survival (PFS). Secondary include R0 rate, 3-year overall survival, distant metastasis-free survival, local control, postoperative complications (CTCAE v5.0), radiotherapy toxicity, quality of life (EORTC QLQ-C30/H\&N35), and surgery-to-radiotherapy interval. Exploratory analyses by margin status, histologic subtype (solid ≥30%), T4a/T4b, and surgical approach. Quality \& data management: Central pathology/imaging review; EDC with range/logic checks; quarterly remote and biannual on-site monitoring with ≥20% source data verification; data dictionary; MDT requirement; independent DSMB every 6 months. Statistical methods: Primary PFS estimated by Kaplan-Meier with 95% CI. Secondary time-to-event endpoints similarly analyzed. QoL longitudinal data using MMRM. Missing data: censoring for PFS; no imputation for safety; MMRM for QoL under MAR.
Study Type
OBSERVATIONAL
Enrollment
70
Postoperative Radiotherapy
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGThird Xiangya Hospital, Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
NOT_YET_RECRUITINGEye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
NOT_YET_RECRUITING3-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.
Time frame: Up to 3 years after enrollment
R0 Resection Rate
Proportion of surgical patients with negative microscopic margins (R0) based on central pathology review. R0 defined as no tumor cells at the inked surgical margin.
Time frame: At time of surgery (postoperative pathological assessment)
3-Year Overall Survival
Time from enrollment to death from any cause. Participants alive at last follow-up are censored. Estimated by Kaplan-Meier method.
Time frame: Up to 3 years after enrollment
3-Year Distant Metastasis-Free Survival
Time from enrollment to first documented distant metastasis (lung, bone, liver, etc.), assessed by annual chest CT and other imaging as clinically indicated. Death without metastasis is censored.
Time frame: Up to 3 years after enrollment
3-Year Local Control Rate
Proportion of patients without local recurrence at the primary tumor site. Local recurrence defined as reappearance of tumor within the nasal cavity, sinuses, or skull base, confirmed by imaging and/or pathology.
Time frame: Up to 3 years after enrollment
Postoperative Complication Rate (CTCAE Grade ≥3)
Incidence of grade 3 or higher postoperative complications according to CTCAE v5.0, including cerebrospinal fluid leak, intracranial infection, hemorrhage, visual loss, palatal defect, and other events within 30 days after surgery.
Time frame: Within 30 days after surgery
Radiotherapy Toxicity Rate (Grade ≥3)
Incidence of grade 3 or higher radiation-related adverse events according to CTCAE v5.0, including mucositis, osteoradionecrosis, optic nerve injury, brain necrosis, and hypopituitarism.
Time frame: From start of radiotherapy up to 3 years
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