NCT06483308进行中（未招募）不适用
Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt) Study
University Hospitals Coventry and Warwickshire NHS Trust6 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年11月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03.
研究概览
简要总结
The SHiP-Rt Study aims to investigate the safety and efficacy of reducing the number of RT fractions and RT duration, compared to the current standard of care (36Gy in 12 fractions over 16 days), by using shortened hypofractionated accelerated palliative radiotherapy (30Gy in 6 alternate-day fractions), aided by contemporary RT planning, verification, and delivery techniques.
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
- •Patient has locally advanced (stage IIIB or IIIC) or metastatic (stage IV) NSCLC
- •Patient is treatment naïve or had limited progression after first-line systemic therapy (using chemotherapy, immunotherapy, or targeted therapy)
- •Patient is suitable for high dose palliative RT (36Gy in 12# or 39Gy in 13#)
- •Obtained written informed consent for the SHiP-Rt study.
- •Patients receiving RT after first-line systemic therapy must have a wash-out period of at least 3 weeks (i.e., 3-4 weeks).
- •Treatment naïve patients should be able to proceed to definitive systemic therapy without undue delay, i.e., within 3-4 weeks.
排除标准
- •Contraindication for thoracic RT
- •Requiring lung RT after second-line systemic therapy for NSCLC
- •Has more than 1 cancer that is requiring active treatment
- •On cytotoxic treatment for rheumatoid arthritis or connective tissue disorders
- •Poor life expectancy, likely less than 6 months
- •Patients with difficulty regarding compliance to the study treatment or follow-up
- •Previous radiotherapy to the same area
研究组 & 干预措施
Radiotherapy
Other
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03.
时间窗: 4 weeks of completing RT
次要结局
- Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03(12 months)
- Number of participants offered to participate in the study vs how many consent vs how many complete treatment(12 months)
- Time to start systemic therapy from recruitment.(12 months)
- Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13)(12 months)
- Disease response and progression(12 months)
- Cost-savings calculations to compare the proposed treatment regime to the standard of care.(12 months)
研究者
研究点 (6)
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