NL-OMON32798尚未招募不适用
A 2-step phase I study evaluating the safety of (neo-)adjuvant cisplatin-pemetrexed and stereotactic radiotherapy for patients with stage IB non-small-cell lung cancer - Cisplatin-pemetrexed and stereotactic radiotherapy in stage IB NSCLC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
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
- •1. Any histologically or cytologically proven NSCLC
- •2. Stage IB NSCLC (T2N0M0)
- •3. FDG-PET scan consistent with stage IB NSCLC
- •4. Age 18 years or older
- •5. Patients should be fit to undergo chemotherapy and be eligible for SRT
- •using 5 or 8 fractions as specified
- •6. Adequate organ function
- •7. signed informed consent
- •8. male and female patients with reproductive potential must use an
- •approved contraceptive method, if appropriate. Female patients with
- •childbearing potential must have a negative serum pregnancy test within
- •7 days prior to study enrollment.
排除标准
- •1. Pregnant or lactating women
- •2. Concomitant treatment with any other experimental drug under
- •investigation.
- •3. Inability or unwillingness to take folic acid or vitamin B-12
- •supplementation
- •4. Diagnosis of a synchronous second malignancy
- •5. Small-Cell Lung cancer (SCLC) or a mixed SCLC-NSCLC
- •6. Prior thoracic radiotherapy
- •7. Prior systemic anti-cancer chemotherapy
研究者
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