Chemoradiotherapy With Very Low Dose Elective Nodal IMRT for Locally Advanced Head & Neck Cancer: the CCRO11 Multi-Institutional Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 76
- 试验地点
- 10
- 主要终点
- To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin.
研究概览
简要总结
Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.
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
- •Biopsy proven squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
- •No surgical resection of primary site or neck dissection (excisional biopsy of lymph node is permitted)
- •Human Papilloma Virus (HPV) testing of tumor performed; HPV p16 by immunohistochemistry
- •Stage III or IVa disease (T1-2N1-3M0, T3-4N0-3M0) excluding T1-2N1 oral cavity and tonsil primaries and any N2C or bilateral N3 disease. Patients with T2N0 cancer of the base of tongue and hypopharynx are eligible
- •ECOG performance status 0-1
- •Age >18 years
- •No current pregnancy
- •No other invasive malignancies within the last 2 years Patients with basal cell or squamous cell skin cancers or carcinoma in situ of any site are eligible.
- •No prior radiotherapy to the head and neck region
- •No prior cisplatin chemotherapy
- •No symptomatic coronary disease or myocardial infarction within the last 6 months
- •Laboratory evaluation: ANC > 2,000/mm3, platelets >100,000/mm3, creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min, bilirubin < 1.5 mg/dl, AST or ALT < 2X upper normal limit
- •Study-specific consent signed prior to entry
排除标准
- •Second primary malignancy that is clinically detectable
- •Inability or unwillingness to comply with chemoRT
- •Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck.
- •Metastatic disease (M1)
- •Pregnant or breast-feeding women.
结局指标
主要结局
To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin.
时间窗: 4 years
次要结局
- To assess actuarial LRC, DFS, and OS rates.(4 years)
- To evaluate patients' quality of life (QOL).(4 years)
- To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.(4 years)