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.
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 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.
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.
Case-control
Prospective
Postoperative Radiotherapy
RadiationIntensity-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
Observation
Other interventionNo 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
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
