ISRCTN15067672进行中（未招募）未知
A randomized multicenter clinical trial for patients with multi-organ, colorectal cancer metastases comparing the combination of chemotherapy and maximal tumor debulking versus chemotherapy alone
Radboud University Medical Centre Nijmegen (Netherlands)0 个研究点目标入组 478 人开始时间: 2020年2月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 478
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
- 性别
- All
入选标准
- •1. Patients with CRC metastases in = 2 different organs and
- •1.1. >3 extrahepatic metastases or
- •1.2. >5 hepatic metastases not located to one lobe or
- •1.3. =1 hepatic metastases and either positive para-aortal lymph nodes or celiac lymph nodes or adrenal metastases or pleural carcinomatosis or peritoneal carcinomatosis
- •1.4. The primary tumor is excluded as metastatic site
- •2. Feasible radical tumor debulking. Incomplete tumor debulking is allowed only if at least 80% of metastases can be treated
- •3. Age >= 18 years
- •4. WHO performance status 0 – 1
- •5. Life expectancy of at least 12 weeks
- •6. Written informed consent
排除标准
- •1. Prior (neo-)adjuvant chemotherapy for < 6 months after last treatment and first detection of extrahepatic metastases, except for neoadjuvant capecitabin in the context of chemoradiation for rectal carcinoma
- •2. Candidates for HIPEC
- •3. Patients with liver metastases only
- •4. Evidence of brain metastases
- •5. History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma of any organ. Patients with other malignancies are eligible if they have remained disease free for at least 5 years
- •6. History of cardiac disease:
- •6.1. Congestive heart failure >NYHA class 2
- •6.2. Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening)
- •6.3. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •7. Uncontrolled hypertension. Blood pressure must be =160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 3 separate measurements on at least 2 separate days
- •8. Uncontrolled infections (> grade 2 NCI-CTC version 4.0)
- •9. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) or intrauterine device during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised.
- •10. Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug
- •11. Concomitant chronic use of dexamethasone, anti-convulsants and anti-arrhythmic drugs other than digoxin or beta blockers
- •12. Severe allergy for contrast media not controlled with premedication
- •13. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results
- •14. Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
研究者
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