the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- efficacy of celecoxib (response rate and local control)
研究概览
简要总结
chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients.This side effect causes significant morbidity and may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase 2 (COX-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. COX-2 inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced toxicities.
we have conducted a phase III, randomized double blind clinical trial to evaluate the toxicity and efficacy of celecoxib, a selective COX-2 inhibitor, administered concurrently with chemotherapy, and radiation for locally advanced head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx
- •primary treatment with chemoradiation
排除标准
- •distant metastasis
- •incomplete treatment
- •adjuvant chemoradiation after surgery without apparent tumor
研究组 & 干预措施
1
干预措施: celecoxib (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
efficacy of celecoxib (response rate and local control)
时间窗: 30 months
次要结局
- toxicity of celecoxib(30 months)