Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

12. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

70

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Quan Liu, MD
  • Telefonnummer: +86 15001959681
  • E-post: liuqent@163.com

Studer Kontakt Backup

Studiesteder

  • Kina
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150001
        • Har ikke rekruttert ennå
        • The Second Affiliated Hospital of Harbin Medical University
        • Ta kontakt med:
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Har ikke rekruttert ennå
        • Third Xiangya Hospital, Central South University
        • Ta kontakt med:
    • Liaoning
      • Shenyang, Liaoning, Kina, 110001
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of China Medical University
        • Ta kontakt med:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200031
        • Rekruttering
        • Eye & ENT Hospital of Fudan University
        • Ta kontakt med:
    • Shanxi
      • Xi’an, Shanxi, Kina, 710032
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Air Force Medical University
        • Ta kontakt med:
    • Zhejiang
      • Wenzhou, Zhejiang, Kina, 325000
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Wenzhou Medical University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Fremgangsmåte: Surgery
Postoperative Radiotherapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
3-Year Progression-Free Survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
R0 Resection Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eye & ENT Hospital of Fudan University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2031

Studiet fullført (Antatt)

1. juni 2031

Datoer for studieregistrering

Først innsendt

12. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026134

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere