JPRN-UMIN000024890招募中未知
Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 400 人开始时间: 2016年11月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 400
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
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- •Criteria for registration
- •? Age >=18 years old
- •? Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
- •Criteria for Eligibility
- •? Primary tumor histologically proven as colorectal adenocarcinoma
- •? Unresectable or borderline resectable liver metastases at the time of diagnosis for liver metastases.
- •? Presence of extrahepatic distant metastases is allowed as long as these lesions are considered as resectable
- •? Contrast-enhanced thorax, abdomen and pelvic CT scanat diagnosis is available
- •? Multiparametric MRI is available.
- •? No contraindications to any contrast agents for CT and MRI or MRI procedure
- •? WHO performance status of 0 or 1
- •? Previous treatments for primary, liver and extra-hepatic metastases are allowed.
- •? No significant comorbidity that will preclude either conversion therapy or surgery
- •? No other malignancies in the 3 years prior to study entry
- •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •? Pregnancy is a contraindication in this study.
- •Criteria for Enrollment
- •? At least 2 cycles of chemotherapy have been given as a part of conversion therapy. Any regimen and schedule of chemotherapy are allowed.
- •? At least 2 sets (at liver metastasis diagnosis and preoperative) of contrast-enhanced CT scan are available
- •? At least 2 sets of multiparametric MRI (baseline and preoperative) are available
- •? Interval between the two MRIs should be at least 4 weeks.
- •? Patient is suitable for hepatic resection based on the assessment of MDT prior to any liver surgery. MDT is composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery. Attendance of pathologist is recommended
- •? Hepatic resection is scheduled within 8 weeks of latest imaging.
排除标准
- 未提供
研究者
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