CTRI/2026/01/102110尚未招募2 期
Study comparing Hypofractionated radiotherapy versus conventional chemoradiation IN Elderly patients with locally advanced head and neck squamous cell carcinoma (SHINE trial):A Phase II open label randomized controlled trial
AIIMS, New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Treatment Response rate
研究概览
简要总结
Elderly patients with advanced head and neck cancer represent a vulnerable population with their unique physiological challenges and comorbidities, requiring tailored approach to address their specific needs. Hypo fractionated radiotherapy has shown promise in improving treatment outcomes, reducing toxicity, and enhancing quality of life for various solid tumors. Hypofractionated treatments in elderly subset has possibility of improving treatment outcomes with reduced acute toxicities and faster treatment delivery improving overall quality of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 65.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 65-75 Eastern Co-operative Oncology Group Performance Score (ECOG PS) 0-2 Biopsy proven locally advanced squamous cell carcinoma of head and neck region including oropharynx, larynx, hypopharynx and oral cavity.
- •Absence of uncontrolled medical comorbidity.
- •Adequate end organ functions &bone marrow reserve.
- •Written Informed consent.
排除标准
- •Age less than 65 or more than 75 Eastern Co-operative Oncology Group Performance Score (ECOG PS) 3-4 Locally advanced biopsy proven squamous cell carcinoma of nasopharyngeal, para-nasal sinus and salivary gland primary.
- •Any prior oncological treatment with surgery, chemotherapy or radiotherapy.
- •Any uncontrolled comorbidity which may compromise delivery of protocol defined chemotherapy and radiotherapy e.g., renal disease, cardiorespiratory disease.
结局指标
主要结局
Treatment Response rate
时间窗: 3 months post treatment
次要结局
- Treatment related late toxicity(3, 6 and 12 months post treatment)
- Quality of Life(Baseline and 3, 6 and 12 months post treatment)
- Locoregional progression free survival(3,6,12 months post treatment)
- Overall survival(3,6,12 months post treatment)
- Distant metastasis free survival(3,6,12 months post treatment)
- Treatment related acute toxicity(Weekly during treatment and 1 month post treatment)
研究者
Dr Anamika Chandra
AIIMS New Delhi
研究点 (1)
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