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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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

70

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Quan Liu, MD
  • 電話番号：+86 15001959681
  • メール：liuqent@163.com

研究連絡先のバックアップ

研究場所

  • 中国
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150001
        • まだ募集していません
        • The Second Affiliated Hospital of Harbin Medical University
        • コンタクト：
    • Hunan
      • Changsha、Hunan、中国、410013
        • まだ募集していません
        • Third Xiangya Hospital, Central South University
        • コンタクト：
    • Liaoning
      • Shenyang、Liaoning、中国、110001
        • まだ募集していません
        • The First Affiliated Hospital of China Medical University
        • コンタクト：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200031
        • 募集
        • Eye & ENT Hospital of Fudan University
        • コンタクト：
    • Shanxi
      • Xi’an、Shanxi、中国、710032
        • まだ募集していません
        • The First Affiliated Hospital of Air Force Medical University
        • コンタクト：
    • Zhejiang
      • Wenzhou、Zhejiang、中国、325000
        • まだ募集していません
        • The First Affiliated Hospital of Wenzhou Medical University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
手順：Surgery
Postoperative Radiotherapy

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
3-Year Progression-Free Survival
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
R0 Resection Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Eye & ENT Hospital of Fudan University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2031年6月1日

研究の完了 (推定)

2031年6月1日

試験登録日

最初に提出

2026年6月12日

QC基準を満たした最初の提出物

2026年6月12日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月17日

QC基準を満たした最後の更新が送信されました

2026年6月12日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026134

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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