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Adenoid Cystic CarcinomaSPORT-SNACCNCT07652489

Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma

An observational study of Adenoid Cystic Carcinoma and Sinonasal Carcinoma, run by Eye & ENT Hospital of Fudan University at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Adenoid Cystic Carcinoma, Sinonasal Carcinoma
What is being tested?
Surgery
Type of treatment
Surgery or procedure
How many people
70 participants
Where
6 sitesChina
Study dates
1 Jun 2026to 1 Jun 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Age 18 80 years, any gender; ECOG performance status 0 2; life expectancy ≥6 months.
  • Histologically confirmed primary sinonasal adenoid cystic carcinoma (cribriform, tubular, solid, or mixed type). Other malignancies excluded.
  • T4 stage (T4a or T4b) according to AJCC 8th edition, based on contrast enhanced MRI/CT.
  • N0 2 (operable lymph node metastasis allowed).
  • 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.
  • Previously untreated (no radiotherapy, chemotherapy, targeted therapy, immunotherapy, or tumor resection). MDT deems technically resectable (R0/R1 achievable, not diffusely unresectable).
  • 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.
  • Willing and able to provide written informed consent for clinical data collection (and optional biospecimen banking). Investigator judges good compliance.

Who cannot join

  • Progressive lung metastases within 6 months (new lesions or >20% increase); extrapulmonary metastases (liver, bone, brain); symptomatic lung metastases.
  • MDT judged unresectable, e.g., bilateral cavernous sinus invasion, brain parenchyma invasion, bilateral internal carotid artery encasement.
  • Primary tumor outside sinonasal cavity (e.g., major salivary glands, oropharynx); non ACC histology.
  • Other active malignancy within 5 years (except cured basal cell carcinoma, cervical carcinoma in situ, etc.).
  • 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).
  • 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.
  • Unable to undergo contrast enhanced MRI (metal implants, claustrophobia, gadolinium allergy); investigator judges inability to complete follow up (e.g., living abroad, substance abuse).

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Quan Liu, MD contact

+86 15001959681

liuqent@163.com

Wanpeng Li, MD contact

+86 13262856870

18879117831@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Third Xiangya Hospital, Central South University

    Changsha, Hunan, 410013

    Guoling Tang, MD, 0731-88638888, guolintan@csu.edu.cn

    Not yet recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Yanan Sun, MD, 0451-86662962, h04015@hrbmu.edu.cn

    Not yet recruiting

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031

    Quan Liu, MD, +86 15001959681, liuqent@163.com

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Hongquan Wei, MD, 024-961200, hongquanwei@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Kaiquan Zhu, MD, 0577-55578167, kaiquanzhu@wzhospital.cn

    Not yet recruiting

  • The First Affiliated Hospital of Air Force Medical University

    Xi’an, Shanxi, 710032

    Xiaodong Chen, MD, 029-84775507, xdchen1981@139.com

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Surgery
Keywords
Carcinoma, Adenoid Cystic, Sinonasal, Radiotherapy, Adjuvant, Prospective Studies, Observational Study, Progression-Free Survival
Medical subject headings
Carcinoma, Adenoid Cystic, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Postoperative Radiotherapy

Study groups in NCT07652489
Study groupRoleWhat they receive
T4 Sinonasal Adenoid Cystic Carcinoma: Surgery plus Postoperative RadiotherapyThis 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.
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 years after enrollment

Secondary outcomes (6)

  1. 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.

    Measured: At time of surgery (postoperative pathological assessment)

  2. 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.

    Measured: Up to 3 years after enrollment

  3. 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.

    Measured: Up to 3 years after enrollment

  4. 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.

    Measured: Up to 3 years after enrollment

  5. 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.

    Measured: Within 30 days after surgery

  6. 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.

    Measured: From start of radiotherapy up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start1 Jun 2026
  3. Primary completion1 Jun 2031 (estimated)
  4. Study completion1 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07652489
Sponsor's protocol ID
2026134
Acronym
SPORT-SNACC
Status last verified
Jun 2026
First submitted
12 Jun 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 28551643

  • 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.

    PubMed 38539566

  • 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.

    PubMed 41089828

  • 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.

    PubMed 30447126

  • 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.

    PubMed 32629365

  • 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.

    PubMed 31463986

  • 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.

    PubMed 37097003

  • 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.

    PubMed 21612974

  • 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.

    PubMed 16757203

Questions about this trial

What is this clinical trial studying?

An observational study of Adenoid Cystic Carcinoma and Sinonasal Carcinoma, run by Eye & ENT Hospital of Fudan University at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Quan Liu, MD (+86 15001959681, liuqent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-Year Progression-Free Survival (time frame: Up to 3 years after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07652489, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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