EUCTR2017-000456-26-DK进行中（未招募）1 期
Predictive value of in-vitro testing anti-cancer therapy sensitivity on tumorspheres from patients with metastatic colorectal cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Metastatic colorectal cancer
- •oBiopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis)
- •oIf only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the colon or rectum (scanning or endoscopy)
- •oNon-resectable metastatic spread
- •Exposed to or intolerance or contraindications to standard systemic therapy, defined as
- •ooxaliplatin
- •oirinotecan
- •o5-fluorouracil (or similar such as capecitabine, S1)
- •oVEGF inhibitor bevacizumab
- •oEGFR inhibitor panitumumab or cetuximab (if RAS/RAF wt)
- •Progressive disease defined as progression according to RECIST 1.1
- •ECOG performance status 0-2
- •Age at least 18 years
- •Adequate bone marrow, liver and renal function allowing systemic chemotherapy
- •oAbsolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/l.
- •oBilirubin = 1.5 x upper normal value and alanine aminotransferase = 3 x upper normal value
- •oCalculated or measured renal glomerular filtration rate at least 30 mL/min
- •Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable
- •Written and orally informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
- •Other active malignant disease requiring therapy
- •Other systemic anti-cancer therapy (palliative radiotherapy is allowed).
- •Pregnant (positive pregnancy test) or breast feeding women
研究者
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