EFFIPEC – Efficacy of Hyperthermic Intraperitoneal Chemotherapy Single-arm Phase I study, followed by an open-label, randomized, controlled registry-based phase III trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 163
- 试验地点
- 4
- 主要终点
- Phase I: Maximum tolerated dose of 5-FU 24-hour EPIC, assessed until 30 days post-treatment. Possible toxicity will be reported as Adverse Events.
研究概览
简要总结
Phase I: To determine the maximum tolerated dose of 5-Fluorouracil 24-hour EPIC, in combination with intensified oxaliplatin/irinotecan HIPEC, for treatment of colorectal cancer.
Phase III: To study the recurrence-free survival (RFS) of patients within 24 months
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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
- 是
入选标准
- •Provision of written informed consent prior to any study specific procedures.
- •ECOG Performance Status Score 0,1 or 2, alternatively Karnofsky 60-
- •Adequate kidney, liver, bone marrow function according to laboratory tests.
- •For females of childbearing potential, a negative pregnancy test must be documented.
- •≥ 18 years old and <=78 years old.
- •Colorectal cancer with peritoneal metastases +/- liver metastases.
- •Concomitant resectable pulmonary metastases.
- •All patients deemed eligible for CRS and HIPEC according to clinical routine.
排除标准
- •Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil
- •Histopathology of other origin than colorectal cancer.
- •Unable to tolerate intensified HIPEC treatment due to comorbidity.
- •Metastasis other than peritoneum or liver or lung (ie paraaortal lymph node or bone metastases)
- •Previous CRS or HIPEC.
- •Pregnant or lactating (nursing) women.
- •Active infections requiring antibiotics.
- •Active liver disease with positive serology for active hepatitis B, C, or known HIV
- •Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment.
- •Incomplete cytoreduction defined as completeness of cytoreduction score 2-3.
结局指标
主要结局
Phase I: Maximum tolerated dose of 5-FU 24-hour EPIC, assessed until 30 days post-treatment. Possible toxicity will be reported as Adverse Events.
Phase I: Maximum tolerated dose of 5-FU 24-hour EPIC, assessed until 30 days post-treatment. Possible toxicity will be reported as Adverse Events.
Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition.
Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition.
次要结局
- To evaluate the overall survival and RFS up to 5 years through the HIPEC registry.
- To evaluate postoperative complication rates within 30 days.
- To evaluate the quality of life of patients up to 3 years after treatment.
研究者
Peter Cashin
Scientific
Uppsala University