Adenoid Cystic CarcinomaSPARE-1stNCT07563088
SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma
An observational study of Adenoid Cystic Carcinoma and Sinonasal Carcinoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenoid Cystic Carcinoma, Sinonasal Carcinoma
- What is being tested?
- Postoperative Radiotherapy and Observation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2032
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 8th 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.
Who may be able to join
- 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 8th 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai
Wanpeng Li, +86 13262856870, 18879117831@163.com
Quan Liu, MD, PhD, +86 15001959681, liuqent@163.com
About this study
Official title: Postoperative Adjuvant Radiotherapy Strategy for Resectable Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Real-World Study
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.
Read more
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.
Read the detailed description
Study Design Overview
This is a prospective, multicenter, observational real-world study conducted at approximately 16 hospitals across China. Patients with completely resected (R0), T1-T3, N0M0 sinonasal adenoid cystic carcinoma (ACC) are enrolled after surgery. The study does not randomize patients; instead, treatment assignment (postoperative radiotherapy vs. observation alone) is determined by shared decision-making between the patient and the attending physician, reflecting routine clinical practice.
Treatment Groups
Radiotherapy group: Patients receive 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, starting within 4-6 weeks after surgery.
Observation group: Patients undergo regular follow-up without postoperative radiotherapy.
All patients receive the same standardized follow-up schedule and supportive care.
Sample Size and Power
A total of 200 patients (approximately 100 per group) are planned. Based on historical data from the lead center (3-year disease-free survival [DFS] of 70% in the radiotherapy group vs. 62% in the observation group, corresponding to a hazard ratio [HR] of 1.35), with a two-sided alpha of 0.05 and power of 80%, this sample size is expected to yield approximately 80-90 DFS events over the 3-year follow-up period.
Statistical Methods
Primary analysis: The non-inferiority of observation versus radiotherapy for 3-year DFS will be assessed using a Cox proportional hazards model with inverse probability of treatment weighting (IPTW) based on propensity scores. The non-inferiority margin is set at HR = 1.35 (upper bound of the 95% confidence interval must be <1.35).
Propensity score model: Includes age, sex, T stage (T1/T2 vs. T3), tumor site, histologic subtype (cribriform/tubular proportion), perineural invasion, margin distance, Ki-67 index, ECOG performance status, and comorbidities.
Sensitivity analyses: Multivariable Cox regression, propensity score matching (1:1, caliper 0.2), instrumental variable analysis (using center preference as the instrument), and E-value analysis will be performed.
Secondary endpoints: Overall survival (1, 3, 5 years), 1-year and 5-year DFS, local control rate, distant metastasis rate, quality of life (EORTC QLQ-C30 and QLQ-H\&N35), and treatment-related toxicity (CTCAE v5.0) will be compared between groups using appropriate methods (Kaplan-Meier, log-rank test, or competing risk models).
Data Collection and Follow-up
Baseline data: Demographics, clinical and pathologic characteristics, surgical details.
Follow-up visits: Every 4 months for the first 2 years, every 6 months for years 3-5, and annually thereafter. Each visit includes physical examination, laboratory tests, and toxicity assessment.
Imaging: Contrast-enhanced MRI every 6 months for the first 3 years and annually for years 4-5 (or whenever clinically indicated). Chest CT annually.
All suspected recurrences are centrally reviewed by a blinded independent central review (BICR) committee using RECIST 1.1 criteria.
Quality Control and Data Monitoring
An independent Data Monitoring Committee (DMC) comprising clinical experts, biostatisticians, and ethicists will review safety data (serious adverse events) every 6 months and overall data quality annually.
Central pathology review confirms the diagnosis and histologic subtype for all enrolled patients.
Electronic data capture (EDC) with source data verification (SDV) will be used. Ethics and Dissemination
The study protocol has been approved by the Ethics Committee of the Eye \& ENT Hospital of Fudan University (approval number: 2026042-1). All participating centers will obtain local ethics approval. Written informed consent will be obtained from all patients. Results will be submitted for publication in peer-reviewed journals regardless of the outcome.
- Conditions
- Adenoid Cystic Carcinoma, Sinonasal Carcinoma
- Being tested
- Postoperative Radiotherapy, Observation
- Keywords
- Sinonasal Adenoid Cystic Carcinoma, Radiotherapy, Adjuvant, Watchful Waiting, Observational Study, Prospective Studies, Non-Inferiority Trials, Disease-Free Survival
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative RadiotherapyRadiation
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
ObservationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment up to 3 years post-treatment
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause. Patients alive at the end of follow-up are censored at the last known alive date.
Measured: 1, 3, and 5 years after treatment
Disease-Free Survival
DFS is defined as the time from enrollment to first occurrence of local recurrence, regional recurrence, distant metastasis, or death from any cause. Patients alive and free from recurrence are censored at the last disease-free assessment. Same definition as primary outcome but assessed at 1-year and 5-year time points.
Measured: 1, and 5 years after treatment
Local Control Rate (LCR)
LCR is defined as the proportion of patients without local recurrence (at the primary tumor site) after treatment. Local recurrence is confirmed by imaging (contrast-enhanced MRI) and/or biopsy, centrally reviewed by blinded independent central review (BICR) using RECIST 1.1 criteria.
Measured: From enrollment up to 5 years
EORTC QLQ-C30
QoL is assessed using the Chinese versions of the EORTC QLQ-C30 (core questionnaire). Scores are calculated according to EORTC scoring manuals. Higher scores represent better functioning or worse symptoms depending on the domain.
Measured: Baseline, and at 6, 12, 24, and 36 months after treatment
QLQ-H&N35
QoL is assessed using the Chinese versions of the QLQ-H\&N35 (head and neck module). Scores are calculated according to EORTC scoring manuals. Higher scores represent better functioning or worse symptoms depending on the domain.
Measured: Baseline, and at 6, 12, 24, and 36 months after treatment
Treatment-Related Toxicity
Toxicity is graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity (occurring ≤90 days from start of radiotherapy or from surgery in the observation group) and late toxicity (occurring >90 days) are recorded separately. Specific toxicities include radiation-induced osteoradionecrosis, xerostomia, trismus, pituitary dysfunction, and second primary malignancies.
Measured: From start of treatment up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Liu, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563088
- Sponsor's protocol ID
- 2026042-1
- Other IDs
- 2026042-1
- Acronym
- SPARE-1st
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 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 will not be shared because this is an investigator-initiated, multicenter observational real-world study. The informed consent form does not include provisions for data sharing beyond the primary research team and participating centers. Data access requests may be considered by the principal investigator upon reasonable request, but no public repository deposit is planned.
Publications
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.
PubMed 31683896Kashiwazaki 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.
PubMed 31194275Wei 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.
PubMed 37100752Seong 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.
PubMed 24080140Lupinetti 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.
PubMed 17960615van 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.
PubMed 25456010Cavalieri 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 32629365Bjorndal 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 21612974Dodd 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Adjuvant Radiotherapy Strategy for Resectable Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Real-World Study
- ClinicalTrials.gov ID
- NCT07563088
- Acronym / sponsor ID
- SPARE-1st / 2026042-1
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design Overview
This is a prospective, multicenter, observational real-world study conducted at approximately 16 hospitals across China. Patients with completely resected (R0), T1-T3, N0M0 sinonasal adenoid cystic carcinoma (ACC) are enrolled after surgery. The study does not randomize patients; instead, treatment assignment (postoperative radiotherapy vs. observation alone) is determined by shared decision-making between the patient and the attending physician, reflecting routine clinical practice.
Treatment Groups
Radiotherapy group: Patients receive 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, starting within 4-6 weeks after surgery.
Observation group: Patients undergo regular follow-up without postoperative radiotherapy.
All patients receive the same standardized follow-up schedule and supportive care.
Sample Size and Power
A total of 200 patients (approximately 100 per group) are planned. Based on historical data from the lead center (3-year disease-free survival [DFS] of 70% in the radiotherapy group vs. 62% in the observation group, corresponding to a hazard ratio [HR] of 1.35), with a two-sided alpha of 0.05 and power of 80%, this sample size is expected to yield approximately 80-90 DFS events over the 3-year follow-up period.
Statistical Methods
Primary analysis: The non-inferiority of observation versus radiotherapy for 3-year DFS will be assessed using a Cox proportional hazards model with inverse probability of treatment weighting (IPTW) based on propensity scores. The non-inferiority margin is set at HR = 1.35 (upper bound of the 95% confidence interval must be <1.35).
Propensity score model: Includes age, sex, T stage (T1/T2 vs. T3), tumor site, histologic subtype (cribriform/tubular proportion), perineural invasion, margin distance, Ki-67 index, ECOG performance status, and comorbidities.
Sensitivity analyses: Multivariable Cox regression, propensity score matching (1:1, caliper 0.2), instrumental variable analysis (using center preference as the instrument), and E-value analysis will be performed.
Secondary endpoints: Overall survival (1, 3, 5 years), 1-year and 5-year DFS, local control rate, distant metastasis rate, quality of life (EORTC QLQ-C30 and QLQ-H\&N35), and treatment-related toxicity (CTCAE v5.0) will be compared between groups using appropriate methods (Kaplan-Meier, log-rank test, or competing risk models).
Data Collection and Follow-up
Baseline data: Demographics, clinical and pathologic characteristics, surgical details.
Follow-up visits: Every 4 months for the first 2 years, every 6 months for years 3-5, and annually thereafter. Each visit includes physical examination, laboratory tests, and toxicity assessment.
Imaging: Contrast-enhanced MRI every 6 months for the first 3 years and annually for years 4-5 (or whenever clinically indicated). Chest CT annually.
All suspected recurrences are centrally reviewed by a blinded independent central review (BICR) committee using RECIST 1.1 criteria.
Quality Control and Data Monitoring
An independent Data Monitoring Committee (DMC) comprising clinical experts, biostatisticians, and ethicists will review safety data (serious adverse events) every 6 months and overall data quality annually.
Central pathology review confirms the diagnosis and histologic subtype for all enrolled patients.
Electronic data capture (EDC) with source data verification (SDV) will be used. Ethics and Dissemination
The study protocol has been approved by the Ethics Committee of the Eye \& ENT Hospital of Fudan University (approval number: 2026042-1). All participating centers will obtain local ethics approval. Written informed consent will be obtained from all patients. Results will be submitted for publication in peer-reviewed journals regardless of the outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery plus Postoperative Radiotherapy Group | – | Radiation: Postoperative RadiotherapySurgery 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. |
| Surgery Alone (Observation) Group | – | Other: ObservationNo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 8th 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.
Key inclusion criteria (11 listed)
- 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 8th edition, with N0 and M0 status.
- Tumor originating from the nasal cavity or paranasal sinuses (excluding primary salivary gland tumors metastatic to this region).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative RadiotherapyIntensity-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 | Radiation | Surgery plus Postoperative Radiotherapy Group |
| ObservationNo 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 | Surgery Alone (Observation) Group |
Primary outcome
3-year Disease-Free Survival (DFS)
Time frame: From enrollment up to 3 years post-treatment
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.
6 secondary outcomes
Overall Survival (OS)
Time frame: 1, 3, and 5 years after treatment
Disease-Free Survival
Time frame: 1, and 5 years after treatment
Local Control Rate (LCR)
Time frame: From enrollment up to 5 years
EORTC QLQ-C30
Time frame: Baseline, and at 6, 12, 24, and 36 months after treatment
QLQ-H&N35
Time frame: Baseline, and at 6, 12, 24, and 36 months after treatment
Treatment-Related Toxicity
Time frame: From start of treatment up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 31683896Akbaba 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.
- Background: PubMed 31194275Kashiwazaki 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.
- Background: PubMed 37100752Wei 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.
- Background: PubMed 24080140Seong 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.
- Background: PubMed 17960615Lupinetti 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.
- Background: PubMed 25456010van 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.
- Background: PubMed 32629365Cavalieri 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.
- Background: PubMed 21612974Bjorndal 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.
- Results publication: PubMed 16757203Dodd 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is an investigator-initiated, multicenter observational real-world study. The informed consent form does not include provisions for data sharing beyond the primary research team and participating centers. Data access requests may be considered by the principal investigator upon reasonable request, but no public repository deposit is planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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 1 site 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 11 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 1 site 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 Disease-Free Survival (DFS) (time frame: From enrollment up to 3 years post-treatment). 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 NCT07563088, 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.