NCT02336711Unknown不适用
Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acute toxicity
研究概览
简要总结
Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.
详细描述
The objective is to assess the feasibility (i.e. early toxicity) of an adaptive dose escalation through 18F-FDG-PET-based dose painting by numbers in 10 HPV negative patients with locally advanced squamous cell carcinoma of the oropharynx. Treatment will be delivered with Helical Tomotherapy® or volumetric-modulated arc therapy (VMAT). Dose adaptation will be performed at 2 time-points with per-treatment 18F-FDG-PET/CT scans.
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
- •Patients older than 18 years
- •Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay)
- •T size of 3 cm or more in greatest dimension with the exclusion of tumor with bone infiltration
- •N0, N1, N2a, N2b node (AJCC/UICC 7th edition)
- •No distant metastasis
- •No contra-indication to concomitant chemotherapy
- •World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥
- •Provision of written informed consent
排除标准
- •Patients with induction chemotherapy will not be eligible
- •Previous or concurrent history of cancer, except basal cell skin carcinoma
- •Second primary tumor at the time of diagnosis
- •Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
- •Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
- •Pregnant or lactating women
研究组 & 干预措施
Dose escalation
Experimental
Dose escalation
干预措施: dose escalation (Radiation)
结局指标
主要结局
Acute toxicity
时间窗: up to 3 months following the completion of radiotherapy
次要结局
- Late toxicity(at 1 and 2 years)
- Overall survival(at 1 and 2 years)
- Progression-free survival(at 1 and 2 years)
- Primary tumor control probability(at 1 and 2 years)
研究者
研究点 (2)
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