ACTRN12621001198819招募中未知
A Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •-Metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery.
- •-Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry
- •-Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-6 months of standard first-line systemic treatment.
- •-3 to 10 metastatic lesions detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans:
- •o maximum of 3 lesions per organ except for the liver and lung
- •o maximum of 5 lesions in the lung
- •o no limit to number of liver lesions provided all are amenable to LAT
- •o maximum of 3 involved organs including a maximum of 2 lymph node stations.
- •-All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.
排除标准
- •-Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen’s disease or prostate cancer with a Gleason score =6.
- •-Presence of brain, peritoneal, omental or ovarian metastases
- •-Malignant pleural effusion or ascites.
研究者
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