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Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma: A Prospective Observational Study (SPORT-SNACC)

2026年6月12日 更新者：Quan Liu、Eye & ENT Hospital of Fudan University

SPORT-SNACC: A Prospective, Multicenter, Observational Cohort Study of Surgery Plus Postoperative Radiotherapy in T4 Sinonasal Adenoid Cystic Carcinoma

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Quan Liu, MD
  • 电话号码：+86 15001959681
  • 邮箱：liuqent@163.com

研究联系人备份

学习地点

  • 中国
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150001
        • 尚未招聘
        • The Second Affiliated Hospital of Harbin Medical University
        • 接触：
    • Hunan
      • Changsha、Hunan、中国、410013
        • 尚未招聘
        • Third Xiangya Hospital, Central South University
        • 接触：
    • Liaoning
      • Shenyang、Liaoning、中国、110001
        • 尚未招聘
        • The First Affiliated Hospital of China Medical University
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200031
        • 招聘中
        • Eye & ENT Hospital of Fudan University
        • 接触：
    • Shanxi
      • Xi’an、Shanxi、中国、710032
        • 尚未招聘
        • The First Affiliated Hospital of Air Force Medical University
        • 接触：
    • Zhejiang
      • Wenzhou、Zhejiang、中国、325000
        • 尚未招聘
        • The First Affiliated Hospital of Wenzhou Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
程序：Surgery
Postoperative Radiotherapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
3-Year Progression-Free Survival
大体时间：Up to 3 years after enrollment
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

次要结果测量

结果测量
措施说明
大体时间
R0 Resection Rate
大体时间：At time of surgery (postoperative pathological assessment)
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
大体时间：Up to 3 years after enrollment
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
大体时间：Up to 3 years after enrollment
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
大体时间：Up to 3 years after enrollment
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)
大体时间：Within 30 days after surgery
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)
大体时间：From start of radiotherapy up to 3 years
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eye & ENT Hospital of Fudan University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2031年6月1日

研究完成 (估计的)

2031年6月1日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026134

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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