Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy: A Multi-center Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Development of osteoradionecrosis (ORN) of the jaw
研究概览
简要总结
Osteoradionecrosis (ORN) of the jaw is a serious complication that can occur after radiation therapy for head and neck cancers, including oral cavity cancer (OCC). ORN happens when jawbone tissue dies and fails to heal, often triggered by dental issues like tooth extractions or poorly fitting dentures. Symptoms can include exposed bone, pain, difficulty opening the mouth, trouble swallowing, and even jaw fractures-leading to major physical and emotional challenges.
The likelihood of ORN varies widely, from less than 1% to over 50% in head and neck cancer patients. For OCC specifically, studies report rates from 4% up to 25%. Treatment depends on how much bone is affected and can range from medication to major surgery.
Risk factors include radiation dose, tumor location, oral health, dental extractions, lifestyle habits (like alcohol use), and other health conditions. Poor oral hygiene, high radiation doses, and alcohol use are among the most common risks. However, current data on OCC patients is limited and often not broadly applicable.
This study will retrospectively examine what increases the risk of ORN in OCC patients who received radiation therapy before or after surgery. Using data from multiple international centers, it aims to identify patterns and provide globally relevant insights. The results will help guide prevention strategies and create evidence-based guidelines to reduce ORN and improve long-term outcomes for these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) diagnosed with OCC and treated with radiotherapy with curative intent (preoperative or/and postoperative, not palliative; definitive RT)
- •Patients who completed the full prescribed radiotherapy course; patients remain eligible if radiotherapy was discontinued due to suspected and subsequently confirmed ORN
- •Available, complete medical records including RT details, oral status, comorbidities, dental procedure details (as applicable), and lifestyle factors (as applicable)
- •Documented informed consent from the treated patient, where applicable, permitting the use of their medical records for research purposes, in accordance with the requirements of the Institutional Review Board (IRB) or Ethics Committee (EC).
- •Availability of at least 24 months of follow-up data after completion of radiotherapy, or follow-up until the occurrence of ORN, death, or loss to follow-up, whichever occurs first.
- •Completion of the radiotherapy course on or before 31 December 2024.
排除标准
- •Patients with non-oral cavity primary cancers (eg, oropharynx, larynx)
- •Patients treated only with surgery or conservatively, without any form of RT
- •Incomplete or missing medical records
- •Record of use of antiresorptive (eg, bisphosphonate, denosumab) and antiangiogenic drugs
- •Patients with jaw necrosis attributable to non-radiation-related causes, such as medication-related osteonecrosis of the jaw (MRONJ), trauma, or odontogenic infections
- •Patients with known metastatic bone disease in the jaw
- •Patients who discontinued radiotherapy for reasons unrelated to ORN suspicion or confirmation (eg, death, dropout, treatment intolerance, or other non-ORN related causes)
研究组 & 干预措施
Cases (ORN group)
Developed clinically and radiographically or histologically confirmed osteoradionecrosis (ORN) of the jaw following radiotherapy.
Control (non-ORN group)
No clinical, radiological, or histological diagnosis of ORN during the follow-up period.
结局指标
主要结局
Development of osteoradionecrosis (ORN) of the jaw
时间窗: After completion of pre-and/or postoperative radiotherapy up to 24 months
The primary outcome is the development occurrence (yes/no) of ORN after completion of pre- and/or postoperative RT. The objective is to identify and evaluate patient-, tumor-, treatment-, and region-related risk factors associated with the development of ORN across multiple geographic regions. Scoring Scale: The primary endpoint will be treated as a binary variable: 0 = No ORN 1 = Development of ORN Time to ORN onset (interval between completion of RT and clinical diagnosis of ORN) will also be recorded for time-to-event analyses.
次要结局
- Incidence and severity comparison of preop vs. postop RT(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- Incidence of ORN Across Geographic Regions(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- Severity of ORN by Tumor Characteristic(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- Association between radiotherapy dose and ORN severity(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- Incidence comparison across RT modalities(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- To determine whether the mandible is more susceptible to ORN than the maxilla, or vice versa.(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- Complication evaluation with pre- or postop RT(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- To analyze the influence of pre-radiotherapy dental extractions and oral hygiene status on the risk of developing ORN(After completion of pre-and/or postoperative radiotherapy up to 24 months)
- To examine the variability in ORN incidence and severity between patients who undergo dental extractions before versus after the completion of RT(After completion of pre-and/or postoperative radiotherapy up to 24 months)