2024-517152-34-00招募中2 期
Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases – a phase II study
Catharina Ziekenhuis Stichting3 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2024年9月3日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- To determine the anti-tumor activity in patients treated with intraperitoneal irinotecan (75 mg) and concomitant palliative systemic therapy, in terms of overall survival (calculated from (a) the interval from diagnosis of peritoneal metastases until death or last follow-up; (b) the interval from the first day of the first cycle until death or last follow-up).
研究概览
简要总结
The main objective is to explore the anti-tumor activity (defined as overall survival) of the addition of intraperitoneal irinotecan (75 mg) to mFOLFOX4 / Bevacizumab in patients with unresectable colorectal peritoneal metastases.
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 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colorectal cancer; - Radiologically and clinically or pathologically confirmed unresectable colorectal peritoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectable disease due to anatomical location); - WHO performance score of 0-1 with a life expectancy of >3 months; - Aged 18 years or older; - Written informed consent.
排除标准
- •Presence of extensive systemic metastases that are deemed to be the dominant factor determining prognosis in terms of life expectancy and performance status [e.g. no imminent threat of impaired organ functioning due to the presence of systemic metastases]); - Prior cytoreductive surgery; - Prior palliative systemic therapy for colorectal cancer; - Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6 months; - Homozygous UGT1A1*28 genotype; - Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency - Microsatellite instable (MSI) primary tumor - Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an absolute neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L, serum creatinine of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin > 2x ULN and liver transaminases of >5 x ULN.
结局指标
主要结局
To determine the anti-tumor activity in patients treated with intraperitoneal irinotecan (75 mg) and concomitant palliative systemic therapy, in terms of overall survival (calculated from (a) the interval from diagnosis of peritoneal metastases until death or last follow-up; (b) the interval from the first day of the first cycle until death or last follow-up).
To determine the anti-tumor activity in patients treated with intraperitoneal irinotecan (75 mg) and concomitant palliative systemic therapy, in terms of overall survival (calculated from (a) the interval from diagnosis of peritoneal metastases until death or last follow-up; (b) the interval from the first day of the first cycle until death or last follow-up).
次要结局
- Patient-reported outcomes (PROs) with EORTC QLQ-CR29(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles. Measured one week after the first cycle, one week after the fourth cycle, one week after the eighth cycle, and one week after the twelfth cycle.)
- Objective radiological response(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles. Measured at baseline, after the fourth cycle, after the eighth cycle, and after the twelfth cycle.)
- Progression-free survival(3 year)
- Toxicity in CTCAE grading(28 weeks. Each cycle is 2 weeks, maximum of 12 cycles. Toxicity measured up to four weeks after last cycle.)
- Productivity loss costs.(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles. Measured one week after the first cycle, one week after the fourth cycle, one week after the eighth cycle, and one week after the twelfth cycle.)
- Occurrence and degree of hepatotoxicity(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles.)
- Occurrence and degree of haematological toxicity(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles.)
- Patient-reported outcomes (PROs) with EQ-5D-5L(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles. Measured one week after the first cycle, one week after the fourth cycle, one week after the eighth cycle, and one week after the twelfth cycle.)
- Healthcare costs(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles. Measured one week after the first cycle, one week after the fourth cycle, one week after the eighth cycle, and one week after the twelfth cycle.)
- Patient-reported outcomes (PROs) with EORTC QLQ-C30(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles. Measured one week after the first cycle, one week after the fourth cycle, one week after the eighth cycle, and one week after the twelfth cycle.)
- Occurrence and degree of nephrotoxicity(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles.)
- Response of Tumor marker during treatment(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles.)
- Peritoneum/plasma ratio of intraperitoneal irinotecan(8 weeks. Each cycles is 2 weeks. Measured during cycle 1 and cycle 4.)
- Number of patients that completed twelve cycles(24 weeks. Each cycle is 2 weeks, maximum of 12 cycles.)
研究者
Jacobus (Pim) Burger
Scientific
Catharina Ziekenhuis Stichting
研究点 (3)
Loading locations...
相似试验
招募中
2 期
Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases - a phase II studyColorectal Cancer with metastasis in the peritoneumPeritoneal carcinomatosis of colorectal origin1003465210017991NL-OMON56200Catharina-ziekenhuis85
已完成
2 期
Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal CancerMetastatic Colorectal CancerNCT01321957Martin-Luther-Universität Halle-Wittenberg250
已完成
2 期
Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated AppendicitisAppendicitis PerforatedNCT03435900Herlev Hospital13
终止
1 期
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT00819754Ottawa Hospital Research Institute23
已完成
2 期
Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal CarcinomaColorectal CarcinomaNCT00176774University of Michigan Rogel Cancer Center24