NL-OMON54123尚未招募3 期
COLLISION RELAPSE trial - Recurrent colorectal liver metastases: repeat local treatment +/- neoadjuvant systemic therapy - a phase III prospective randomized controlled trial - COLLISION RELAPSE - Repeat local treatment +/- neoadjuvant systemic therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 360
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
- •- Histological documentation of primary colorectal tumor
- •- Local treatment performed for initial CRLM
- •- >=1 locally treatable recurrent CRLM (partial hepatectomy and/or thermal
- •- Resection for resectable lesions considered possible obtaining negative
- •resection margins (R0) and preserving adequate liver reserve
- •- Total number of new CRLM <= 5
- •- No microsatellite instability (MSI)
- •- Good performance status (ECOG 0-2) // ASA 1-3
- •- No extrahepatic disease
- •- Both chemo-naïve patients and patients who did not progress on either CAPOX,
- •FOLFOX, or FOLFIRI chemotherapy prior to the initial local treatment
排除标准
- •- Pregnant or breast-feeding subjects. Women of childbearing potential must
- •have a negative pregnancy test performed within 7 days of the start of
- •- Immunotherapy <= 6 weeks prior to the randomization;
- •- Chemotherapy <= 6 weeks prior to the randomization;
- •- Progression on both oxaliplatin and irinotecan;
- •- Severe allergy to contrast media not controlled with premedication.
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