Postoperative Adjuvant Radiotherapy Strategy for Resectable Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter, Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究者
Quan Liu
Director of Skull Base Adenoid Cystic Carcinoma Center; Chief Physician of Otolaryngology Department
Eye & ENT Hospital of Fudan University