Omission of Prophylactic Impacted Tooth Extraction and Risk of Jaw Osteoradionecrosis in Nasopharyngeal Carcinoma: A Multicenter, Noninferiority, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 536
- 试验地点
- 11
- 主要终点
- 2-Year Cumulative Incidence of Jaw Osteoradionecrosis
研究概览
简要总结
This multicenter, randomized controlled trial is designed to determine whether omitting prophylactic extraction of impacted teeth before radiotherapy leads to an unacceptably higher risk of jaw osteoradionecrosis (JORN) compared with conventional prophylactic extraction in patients with non-metastatic nasopharyngeal carcinoma (NPC). JORN is a condition in which jawbone tissue is damaged and fails to heal properly after radiotherapy.
A total of 536 eligible participants with at least one impacted tooth will be randomly assigned to either omit prophylactic extraction of impacted teeth before radiotherapy or undergo conventional prophylactic extraction before radiotherapy. All participants will receive standard curative-intent intensity-modulated radiotherapy (IMRT), with chemotherapy administered when indicated according to the study protocol.
Participants will be followed for up to 5 years. The primary outcome is the incidence of JORN within 2 years after completion of radiotherapy. Secondary outcomes include longer-term incidence of JORN, overall survival, locoregional relapse-free survival, distant metastasis-free survival, quality of life, and treatment-related toxicities.
详细描述
Prophylactic extraction of impacted teeth before radiotherapy is performed to reduce the potential risk of dental complications and jaw osteoradionecrosis after treatment. However, whether prophylactic extraction is necessary for impacted teeth without indications for therapeutic extraction remains uncertain.
This study is designed to evaluate whether omission of prophylactic impacted tooth extraction is noninferior to conventional prophylactic extraction with respect to the risk of jaw osteoradionecrosis in patients with non-metastatic nasopharyngeal carcinoma undergoing curative-intent radiotherapy. The study will also assess the long-term clinical outcomes and safety of this tooth-management strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Age 18-75 years, regardless of sex.
- •Histologically confirmed non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype (WHO type II or III).
- •Newly diagnosed, previously untreated nasopharyngeal carcinoma with stage T1-4N0-3M0 according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
- •Presence of permanent dentition with at least one impacted third molar.
- •Adequate bone marrow function, defined as white blood cell count ≥4.0 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥90 g/L.
- •Adequate hepatic function, defined as alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal (ULN), and total bilirubin ≤1.5 × ULN.
- •Adequate renal function, defined as blood urea nitrogen and serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL/min.
- •Coagulation function within normal limits.
- •Written informed consent provided, with willingness and ability to comply with study visits, treatment plans, laboratory assessments, and other study procedures.
排除标准
- •Histopathological diagnosis other than WHO type II or III nasopharyngeal carcinoma.
- •Impacted third molars with recurrent pericoronitis or inflammation due to incomplete eruption.
- •Fully erupted third molars with dental caries involving the pulp.
- •Impacted third molars with radiographic evidence of periapical or periodontal inflammation.
- •Third molars completely impacted within the jawbone.
- •History of active malignancy or other malignant tumors diagnosed within the previous 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
- •Previous chemotherapy, surgery (except diagnostic procedures), radiotherapy, or other antitumor treatment for nasopharyngeal carcinoma or cervical lesions.
- •Patients receiving palliative treatment.
- •Pregnant or breastfeeding women.
- •Severe uncontrolled cardiovascular or cerebrovascular diseases.
- •Severe hepatic or renal dysfunction.
- •Uncontrolled diabetes mellitus.
- •Severe osteoporosis, medication-related osteonecrosis/osteomyelitis, or chronic diseases requiring long-term systemic corticosteroid therapy.
- •Other severe chronic debilitating diseases that may increase study risk or affect study compliance.
- •History of drug abuse or alcohol dependence.
- •Uncontrolled psychiatric disorders or inability to provide legally valid informed consent.
- •Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1,000 copies/mL.
- •Active hepatitis C virus infection (positive HCV RNA).
- •Human immunodeficiency virus (HIV) infection or diagnosis of acquired immunodeficiency syndrome (AIDS).
- •Active tuberculosis within the previous 1 year.
- •History of active tuberculosis more than 1 year previously without documented completion of standard anti-tuberculosis treatment.
- •Any other medical, psychological, social, or laboratory condition that, in the investigator's judgment, may compromise participant safety, interfere with study procedures, affect protocol compliance, or result in premature withdrawal from the study.
- •Refusal or inability to provide written informed consent.
研究组 & 干预措施
Omission of Prophylactic Extraction Group
Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.
干预措施: Omission of Prophylactic Impacted Tooth Extraction (Other)
Conventional Prophylactic Extraction Group
Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.
干预措施: Prophylactic Impacted Tooth Extraction (Procedure)
结局指标
主要结局
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
时间窗: Within 24 months after completion of radiotherapy
The cumulative incidence of jaw osteoradionecrosis (JORN) within 24 months after completion of radiotherapy will be estimated and compared between the two treatment groups.
次要结局
- 2-Year Overall Survival(24 months after randomization)
- 2-Year Event-Free Survival(24 months after randomization)
- 2-Year Local Relapse-Free Survival(24 months after randomization)
- 2-Year Regional Relapse-Free Survival(24 months after randomization)
- 2-Year Distant Metastasis-Free Survival(24 months after randomization)
- Quality of Life Assessed by the EORTC QLQ-C30(Baseline and 3, 6, 12, and 24 months after completion of radiotherapy)
- Head and Neck Cancer-Specific Quality of Life Assessed by the EORTC QLQ-H&N35(Baseline and 3, 6, 12, and 24 months after completion of radiotherapy)
- Acute Treatment-Related Toxicities(From initiation of treatment through 90 days after completion of radiotherapy)
- 5-Year Cumulative Incidence of Jaw Osteoradionecrosis(Within 60 months after completion of radiotherapy)
- 5-Year Overall Survival(60 months after randomization)
- 5-Year Event-Free Survival(60 months after randomization)
- 5-Year Local Relapse-Free Survival(60 months after randomization)
- 5-Year Regional Relapse-Free Survival(60 months after randomization)
- 5-Year Distant Metastasis-Free Survival(60 months after randomization)
- Late Treatment-Related Toxicities(From more than 90 days through 60 months after completion of radiotherapy)
研究者
min kang
Director of Radiation Oncology Department, The First Affiliated Hospital of Guangxi Medical University
First Affiliated Hospital of Guangxi Medical University