A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.
详细描述
Many studies have shown the superiority of concurrent chemoradiotherapy over radiotherapy only in locally advanced head and neck cancer. Concurrent chemoradiotherapy with high dose cisplatin has been universally used regimen. In a large-scaled phase II trial, however, conducted by the European Organization for the Research and Treatment of Cancer (EORTC), docetaxel (100mg/m2) plus cisplatin (75mg/ m2) every three weeks regimen produced improved survival, nonetheless there was significant limitation to deliver full doses of treatment due to significant hematologic and non-hematologic toxicities. Previously, we showed the safety of the combination regimen of weekly docetaxel and cisplatin in concurrent chemoradiation treatment in a phase I study. We determined the MTD of docetaxel to be 20mg/m2 weekly when concurrently administered with conventional fractionation RT and weekly 20mg/m2 of cisplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx
- •Unresectable Stage III - ⅣB disease
- •previously untreated for head & Neck cancer with chemotherapy or radiotherapy
- •18 and over
- •Performance status ECOG 0-1
- •Absolute neutrophil count ≥ 1,500/mm3
- •Platelet count ≥ 75,000/mm3
- •Hemoglobin > 9.0 g/dL
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:Alkaline phosphatase ≤ 1.5 times ULN AND AST or ALT ≤ 5 times ULN Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN
- •serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min
排除标准
- •Distant metastatic disease (M1)
- •Prior chemotherapy or RT for Head and neck cancer
- •Synchronous or concurrent head and neck primary tumors
- •Lip, nasopharynx, nasal cavity, salivary gland, or sinuses
- •No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer
- •Other concurrent illness that would preclude study participation
- •Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
- •pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after study participation
研究组 & 干预措施
weekly docetaxel and cisplatin
干预措施: CCRT with weekly docetaxel & cisplatin (Drug)
结局指标
主要结局
Complete response rate
时间窗: 3-4 weeks after completion of CCRT
次要结局
- overall survival rate(2 year)
- quality of life(Pretreatment & 3-4 weeks after completion of treatment)
- disease free survival rate(2 year)
研究者
Keunchil Park
Principal investigator
Samsung Medical Center