CTRI/2024/10/075865尚未招募不适用
Evaluating the Role of PET-CECT Based Radiation Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients - A phase II, Prospective, Single Institution Study
N/A1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Local Control
研究概览
简要总结
Head and neck squamous cell carcinoma (HNSCC) represents a significant clinical challenge due to its aggressive nature and potential for local and distant spread. Standard radiation therapy planning often lacks precision in targeting hypermetabolic regions, which may contribute to suboptimal treatment outcomes. The integration of positron emission tomography-computed tomography (PET-CECT) in radiation planning allows for the identification of hypermetabolic regions, potentially enabling dose escalation specifically to these areas. This approach may improve local control and overall survival while maintaining manageable levels of treatment-related toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of HNSCC 2)Tumour sites.
- •head and neck 3)Age.
- •adults between 18-75 years 4)Performance status.
- •ECOG 1-2 5)No prior head and neck radiation therapy.
- •patients undergoing radical/ definitive RT/RT-CT 6)Patients who have understood and agreed to participate in the study by signing written informed consent including regular follow-up.
排除标准
- •Tissue biopsy diagnosis other than HNSCC 2)Postoperative patients 3)Prior head and neck irradiation 4)Metastatic disease/ palliative status 5)Severe comorbidities 6)Pregnancy 7)Contraindications to PET-CECT 8)Patients unwilling to participate in study.
结局指标
主要结局
Local Control
时间窗: 3 months
次要结局
- Progression-free Survival(1 year)
- Overall Survival(1 year)
- Treatment-related toxicity(1 year)
- Quality of life(1 year)
研究者
Anoushka Taneja
Kasturba Medical College, Manipal
研究点 (1)
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