NCT03251612已完成2 期
Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Progression free survival 8 weeks after start of treatment
研究概览
简要总结
The purpose of the present study is to investigate the benefit of anti-cancer therapy administered on the basis of drug sensitivity testing. This concerns colorectal cancer patients who have previously received standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic colorectal cancer
- •Biopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis)
- •If 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)
- •Non-resectable metastatic spread
- •Previously exposed to or intolerance or contraindications to standard systemic therapy, defined as
- •oxaliplatin
- •irinotecan
- •5-fluorouracil (or similar such as capecitabine, S1)
- •VEGF inhibitor bevacizumab
- •EGFR 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
- •Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l.
- •Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value
- •Calculated 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
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
研究组 & 干预措施
Treatment
Other
1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.
干预措施: Based on sensitivity analysis (Drug)
结局指标
主要结局
Progression free survival 8 weeks after start of treatment
时间窗: 42-63 days after start of treatment
次要结局
- Quality of life as measured by questionnaire EQ-5D-5L(Every 8 weeks up to 2.5 years)
- Progression free survival(Every 8 weeks until progression or death up to 2.5 years)
- Overall survival(Every 3 months up to 2.5 years)
- Response rate(Every 8 weeks until progression up to 2.5 years)
研究者
研究点 (4)
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