NCT04933357Unknown2 期
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging
National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年9月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Loco-regional control of HNSCC patients.
研究概览
简要总结
This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx.
- •Clinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT).
- •Informed consent obtained, signed and dated before specific protocol procedures.
排除标准
- •Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.
研究组 & 干预措施
Dose escalation
Experimental
干预措施: Dose escalation (Radiation)
Standard dose
Active Comparator
干预措施: Standard dose (Radiation)
结局指标
主要结局
Loco-regional control of HNSCC patients.
时间窗: 2 years loco-regional control.
次要结局
- Overall survival(2 years overall survival)
- Acute radiation toxicity(During treatment and up to 6 months post treatment.)
- Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.(2-4 weeks after start of treatment)
研究者
Roa AbdulRahim El-Tagy
assistant lecturer
National Cancer Institute, Egypt
研究点 (1)
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