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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Postoperative Radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of surgery (postoperative pathological assessment) |
| 3-Year Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Liu, MD | Contact | +86 15001959681 | liuqent@163.com | |
| Wanpeng Li, MD | Contact | +86 13262856870 | 18879117831@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28551643 | Result | 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. | |
| 38539566 | 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. |
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Individual participant data (IPD) will not be shared because the informed consent obtained from participants does not include provisions for data sharing beyond the primary research team. Additionally, the data contain potentially identifiable clinical and imaging information. Aggregate results will be published, but IPD will remain within the study sites for regulatory and ethical compliance.
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| ID | Term |
|---|---|
| D003528 | Carcinoma, Adenoid Cystic |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Time from enrollment to death from any cause. Participants alive at last follow-up are censored. Estimated by Kaplan-Meier method. |
| 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. | 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. | 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. | 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. | From start of radiotherapy up to 3 years |
| Third Xiangya Hospital, Central South University | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| The First Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
|
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
|
| The First Affiliated Hospital of Air Force Medical University | Not yet recruiting | Xi’an | Shanxi | 710032 | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| 41089828 | 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. |
| 30447126 | 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. |
| 32629365 | 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. |
| 31463986 | 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. |
| 37097003 | 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. |
| 21612974 | 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. |
| 16757203 | 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. |