SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma

NCT07563088 | Not Yet Recruiting DMC

• 1 other identifier: 2026042-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sinonasal adenoid cystic carcinoma (ACC) is a rare type of cancer that starts in the nasal cavity or sinuses. Although surgery can remove the tumor, doctors often recommend radiation therapy after surgery to reduce the chance of the cancer coming back. However, radiation can cause long-term side effects such as bone damage, dry mouth, or difficulty opening the mouth. For patients whose tumor has been completely removed (called R0 resection) and who have early-stage disease (T1-T3) without spread to lymph nodes or other organs, it is not clear whether routine radiation therapy is always needed. Study Objective: This study aims to find out whether simply watching and waiting (surgery alone) is not worse than adding radiation therapy (surgery plus radiation) in terms of keeping patients free from cancer for at least 3 years. If surgery alone is shown to be as good as surgery plus radiation, some patients may be able to avoid the side effects of radiation. Study Design: This is a prospective, multicenter, real-world study. It is not a randomized trial - patients and their doctors will decide together whether to have radiation after surgery. We will follow about 200 patients from many hospitals across China. About half will receive surgery alone, and the other half will receive surgery followed by radiation therapy. All patients will be followed for at least 3 years. Hypothesis: We hypothesize that surgery alone is not inferior to surgery plus radiation therapy for 3-year disease-free survival, with a non-inferiority margin of a hazard ratio of 1.35. In other words, even if surgery alone has a slightly higher risk of cancer returning, the difference is small enough that avoiding radiation side effects may still be worthwhile. Main Outcome: The main outcome is the percentage of patients who are alive and free from cancer recurrence (local, regional, or distant) or death from any cause at 3 years after treatment. Potential Impact: If our hypothesis is confirmed, this study could change current practice. Many patients with completely resected, early-stage sinonasal ACC might safely avoid postoperative radiation and its long-term side effects, improving their quality of life without compromising cancer control.

Conditions

Adenoid Cystic Carcinoma; Sinonasal Carcinoma

Keywords

Sinonasal Adenoid Cystic Carcinoma; Radiotherapy; Adjuvant; Watchful Waiting; Observational Study; Prospective Studies; Non-Inferiority Trials; Disease-Free Survival

Outcome Measures

Primary Outcomes (1)

• 3-year Disease-Free Survival (DFS)

  DFS is defined as the time from enrollment to the first occurrence of any of the following events: local recurrence, regional recurrence (cervical lymph nodes), distant metastasis, or death from any cause. Patients alive and free from recurrence are censored at the last disease-free assessment. All suspected recurrences are centrally reviewed by a blinded independent central review (BICR) committee using RECIST 1.1 criteria.

  From enrollment up to 3 years post-treatment

Secondary Outcomes (6)

• Overall Survival (OS)

  1, 3, and 5 years after treatment

• Disease-Free Survival

  1, and 5 years after treatment

• Local Control Rate (LCR)

  From enrollment up to 5 years

• EORTC QLQ-C30

  Baseline, and at 6, 12, 24, and 36 months after treatment

• QLQ-H&N35

  Baseline, and at 6, 12, 24, and 36 months after treatment

Study Arms (2)

Surgery plus Postoperative Radiotherapy Group

Surgery plus Postoperative Radiotherapy:Participants in this group undergo radical surgical resection of the tumor (R0 resection) followed by postoperative intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) at a dose of 60-66 Gy to the high-risk clinical target volume (CTV1) and 54-60 Gy to the low-risk CTV2. Radiotherapy is initiated within 4-6 weeks after surgery.

Radiation: Postoperative Radiotherapy

Surgery Alone (Observation) Group

No postoperative radiotherapy or any other form of adjuvant radiation. Patients undergo regular follow-up according to the study protocol, including physical examination, laboratory tests, and imaging (contrast-enhanced MRI of the head and neck every 6 months for the first 3 years and annually thereafter; chest CT annually). Active surveillance is performed to detect any recurrence or metastasis.

Other: Observation

Interventions

Postoperative Radiotherapy RADIATION

Intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) delivered to the postoperative tumor bed. High-risk clinical target volume (CTV1) receives 60-66 Gy in 30-33 fractions (1.8-2.0 Gy per fraction). Low-risk clinical target volume (CTV2) receives 54-60 Gy in 30-33 fractions. Treatment starts within 4-6 weeks after surgery. Daily image guidance is used. Organs at risk are constrained according to QUANTEC/RTOG guidelines

Surgery plus Postoperative Radiotherapy Group

Observation OTHER

No postoperative radiotherapy or any other form of adjuvant radiation. Patients undergo regular follow-up according to the study protocol, including physical examination, laboratory tests, and imaging (contrast-enhanced MRI of the head and neck every 6 months for the first 3 years and annually thereafter; chest CT annually). Active surveillance is performed to detect any recurrence or metastasis

Surgery Alone (Observation) Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (age 18-75 years) with histologically confirmed cribriform or tubular type sinonasal adenoid cystic carcinoma, who have undergone R0 surgical resection and have disease staged as T1-T3, N0, M0 per AJCC 9th edition. Participants are recruited from the Department of Otolaryngology of approximately 16 tertiary hospitals across China, including the lead center (Eye \& ENT Hospital of Fudan University) and collaborating centers. Consecutive patients meeting eligibility criteria are invited to enroll after providing written informed consent. Treatment assignment (postoperative radiotherapy vs. observation alone) is determined by shared decision-making between the patient and the attending physician, reflecting routine clinical practice.

You may qualify if:

• Age ≥18 years and ≤75 years.
• Histologically confirmed adenoid cystic carcinoma of cribriform or tubular type (solid type excluded) by central pathology review.
• Completed radical surgical resection with postoperative pathology confirming R0 resection (negative microscopic margins).
• Tumor stage T1, T2, or T3 according to AJCC 9th edition, with N0 and M0 status.
• Tumor originating from the nasal cavity or paranasal sinuses (excluding primary salivary gland tumors metastatic to this region).
• ECOG performance status 0 or 1.
• Adequate bone marrow, liver, and kidney function within 14 days before enrollment:
• Absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥90 g/L.
• Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN.
• Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
• Willing and able to provide written informed consent.

You may not qualify if:

• Tumor stage T4, or presence of regional lymph node metastasis (N+), or distant metastasis (M1).
• Postoperative pathology showing positive margins (R1 or R2).
• Prior head and neck radiotherapy.
• Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
• Uncontrolled serious concomitant disease (e.g., unstable angina, recent myocardial infarction, uncontrolled hypertension).
• Pregnant or breastfeeding women, or women of childbearing age not using effective contraception.
• Psychological, social, or geographic factors that may interfere with study compliance.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

Location

Related Publications (9)

• Akbaba S, Ahmed D, Mock A, Held T, Bahadir S, Lang K, Syed M, Hoerner-Rieber J, Forster T, Federspil P, Herfarth K, Plinkert P, Debus J, Adeberg S. Treatment Outcome of 227 Patients with Sinonasal Adenoid Cystic Carcinoma (ACC) after Intensity Modulated Radiotherapy and Active Raster-Scanning Carbon Ion Boost: A 10-Year Single-Center Experience. Cancers (Basel). 2019 Nov 1;11(11):1705. doi: 10.3390/cancers11111705.

  PMID: 31683896 BACKGROUND

• Kashiwazaki R, Turner MT, Geltzeiler M, Fernandez-Miranda JC, Gardner PA, Snyderman CH, Wang EW. The endoscopic endonasal approach for sinonasal and nasopharyngeal adenoid cystic carcinoma. Laryngoscope. 2020 Jun;130(6):1414-1421. doi: 10.1002/lary.28100. Epub 2019 Jun 13.

  PMID: 31194275 BACKGROUND

• Wei W, Liu JQ, Qi Y, Li XM, Meng FY, Ren QZ, Yan B, Wang ZL, Zhang QH. [Analysis of the efficacy of endoscopic transnasal surgery for sinonasal and skull base adenoid cystic carcinoma]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2023 May 7;58(5):438-444. doi: 10.3760/cma.j.cn115330-20221107-00666. Chinese.

  PMID: 37100752 BACKGROUND

• Seong SY, Hyun DW, Kim YS, Cho HJ, Lee JG, Yoon JH, Kim CH. Treatment outcomes of sinonasal adenoid cystic carcinoma: 30 cases from a single institution. J Craniomaxillofac Surg. 2014 Jul;42(5):e171-5. doi: 10.1016/j.jcms.2013.08.002. Epub 2013 Sep 9.

  PMID: 24080140 BACKGROUND

• Lupinetti AD, Roberts DB, Williams MD, Kupferman ME, Rosenthal DI, Demonte F, El-Naggar A, Weber RS, Hanna EY. Sinonasal adenoid cystic carcinoma: the M. D. Anderson Cancer Center experience. Cancer. 2007 Dec 15;110(12):2726-31. doi: 10.1002/cncr.23096.

  PMID: 17960615 BACKGROUND

• van Weert S, van der Waal I, Witte BI, Leemans CR, Bloemena E. Histopathological grading of adenoid cystic carcinoma of the head and neck: analysis of currently used grading systems and proposal for a simplified grading scheme. Oral Oncol. 2015 Jan;51(1):71-6. doi: 10.1016/j.oraloncology.2014.10.007. Epub 2014 Oct 28.

  PMID: 25456010 BACKGROUND

• 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.

  PMID: 32629365 BACKGROUND

• 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.

  PMID: 21612974 BACKGROUND

• 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.

  PMID: 16757203 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sample tissues

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Observation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Quan Liu, MD

CONTACT

+86 15001959681; liuqent@163.com

Wanpeng Li, MD

CONTACT

+86 13262856870; 18879117831@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Skull Base Adenoid Cystic Carcinoma Center; Chief Physician of Otolaryngology Department

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2032
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)