ISRCTN17123858进行中（未招募）Unknown
PRINCE: Prospective, randomised, multicentre trial of first line systemic treatment and radiotherapy in stage IV non-small cell lung cancer
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 472
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. >=16 years of age
- •2. Stage IV non-small cell lung cancer (NSCLC) (radiological diagnosis confirmed at multidisciplinary team [MDT] as a minimum) (additionally see #6 trial-specific requirement below)
- •3. Thoracic disease amenable to radiotherapy
- •4. Provision of written informed consent
- •5. For women of childbearing potential: a negative urine or serum pregnancy test within 7 days of trial entry into the main trial
- •6. Histologically or cytologically confirmed NSCLC
- •7. At least T2 and/or N1 disease
- •8. ECOG Performance Status (0-2)
- •9. The patient is deemed fit to receive a minimum of four cycles of systemic anti-cancer treatment according to local guidelines and assessment
- •10. Fit to receive high-dose palliative radiotherapy with acceptable pulmonary function according to local guidelines and assessment
排除标准
- •1. The need for palliative radiotherapy to the thorax prior to randomisation
- •2. Co-morbidities which are considered a contraindication to radiotherapy by the treating clinical team, including interstitial lung disease and active connective tissue disorders
- •3. History of prior malignant tumours likely to interfere with the protocol treatment or comparisons
- •4. Leptomeningeal disease
- •5. Women who are pregnant or breastfeeding
- •6. Women of child-bearing potential who are not able or unwilling to use a highly effective method of contraception
- •7. Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol
- •8. Primary targeted systemic therapy for NSCLC with a driver mutation (EGFR, ALK, ROS-1, BRAF)
- •9. Prior treatments for this NSCLC*
- •10. Patients participating in a clinical trial of an investigational medicinal product
- •*Cycle 1 of standard-of-care systemic therapy for this NSCLC may be delivered prior to randomisation
研究者
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