NL-OMON35252招募中3 期
Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small cell lung cancer: A phase III randomized study (NVALT-11/ DLCRG-02). - NVALT-11/DLCRG-02
ederlandse Vereniging van artsen voor Longziekten en Tuberculose0 个研究点目标入组 450 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
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
- 年龄范围
- 18 至 99（—）
入选标准
- •4.1 Eligibility for registration
- •1. UICC stage III A or IIIB (without malignant pleural or pericardial effusion) non-small cell lung cancer (histology or cytology)
- •2. Whole body FDG-PET-scan before the start of therapy available: No distant metastases
- •3. CT or MRI of the brain before the start of therapy available: No brain metastases
- •4. No other malignancy in the preceding 2 years, except non-melanoma skin cancer or any carcinoma in situ.
- •5. No prior cranial irradiation
- •6 Patient should be suitable for radical treatment with Platinum-based chemotherapy and is planned to receive radical loco-regional therapy: concurrent or sequential chemotherapy (Platinum-based) and radiotherapy with or without surgery (Radiotherapy dose without surgery at least a biological equivalent of 60 Gy (20))
- •7. Patients must sign a study-specific informed consent at the time of registration. At the same time, thus before randomization, the baseline forms (CTCAE3.0, QLQ-C30 and EuroQol 5D) should be filled out.
- •8. Pregnant women are ineligible as treatment involves unforeseen risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception
- •4.2 Conditions for Patient eligibility at randomization
- •1. Patient has been registered in the study and has completed appropriate radical treatment, no more than 6 weeks before. Registration is thus allowed either before or after radical therapy.
- •2 The patient is ready to receive PCI within 1 week of randomization (if randomized to PCI arm)
- •3. There is no clinical evidence of progressive disease after chemo-radiation (no imaging is requested)
- •4. No evidence of extracranial distant metastatic disease
- •5. Signed informed consent for randomization
排除标准
- 未提供
研究者
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