NCT06681038尚未招募2 期
Systemic Antitumor Treatment with or Without Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Colon Peritoneal Metastases - a Multicentre Phase II Randomized Trial (PIPOX02)
Institut Cancerologie de l'Ouest15 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 15
- 主要终点
- Progression free survival (PFS) between the two groups
研究概览
简要总结
The goal of this clinical trial is to learn if Pressurized intraperitoneal aerosol chemotherapy (PIPAC) significantly improve the progression-free survival (PFS) in patients with advanced peritoneal metastasis from colorectal cancer.
Researchers will compare 2 strategies, systemic treatments (chemotherapy + targeted therapy) corresponding to standard treatment with or without intraperitoneal oxaliplatin (PIPAC) to see if PIPAC improve the progression-free survival.
Participants will:
- receive a standard treatment every 2 weeks for 12 cycles of intravenous FOLFIRI or FOLFIRINOX + targeted systemic therapy (anti-EGFR or anti-VEGF) in the both arms.
- receive up to a maximum of 4 PIPAC every 6 weeks with pressurized aerosol containing oxaliplatin in experimental arm.
- receive a maintenance treatment until progression or until the onset of severe toxicity after 12 cycles.
- be asked to perform a CT scan and carcinoembryonic antigen (CEA) assay every 8 weeks until progression
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •ECOG performance status of 0 to 2;
- •Histopathologically confirmed colonic adenocarcinoma with synchronous or metachronous peritoneal metastasis (PM);
- •Unresectable PM defined as any of the following:
- •Extended small bowell involvement
- •Poor general condition contra-indication to a major abdominal surgery (eg: a complete cytoreductive surgery), as decided by the medico-surgical team of the investigator's site specialised in peritoneal carcinomatosis in charge of the patient.
- •A surgical exploration performed less than 4 weeks before inclusion (if not, a laparoscopic exploration must be performed);
- •First line systemic chemotherapy for advanced / metastatic colonic adenocarcinoma. Systemic chemotherapy in an adjuvant setting is allowed if completed more than 6 months before recurrence and without persistent oxaliplatin-induced neuropathy;
- •No extended intraperitoneal adherences defined by at least 9 out of 13 abdominal regions correctly explored during surgical exploration (laparoscopy or laparotomy;
排除标准
- •Other cancer treated within the last 3 years, with the exception of in situ cervical carcinoma or basocellular carcinoma;
- •Rectal cancer primary (tumor <15 cm from the anal verge);
- •Mutational status corresponding to microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);
- •Complete or partial bowel obstruction unresponsive to medical treatment;
- •Extraperitoneal polymetastatic diseases. (Only oligometastatic1 diseases are allowed for inclusion);
- •History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 6 months prior to enrolment;
- •Active gastrointestinal bleeding;
- •Inflammatory bowel disease;
- •Peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0, grade ≥2
研究组 & 干预措施
Control ARM
Active Comparator
Systemic treatments
干预措施: Standard Medical Therapy (Drug)
Experimental ARM
Experimental
PIPAC procedure with pressurized aerosol containing oxaliplatin.
干预措施: Standard Medical Therapy (Drug)
Experimental ARM
Experimental
PIPAC procedure with pressurized aerosol containing oxaliplatin.
干预措施: PIPAC (Procedure)
结局指标
主要结局
Progression free survival (PFS) between the two groups
时间窗: From randomisation to 18 months after last patient randomisation
Progression free survival (PFS) is defined as the time (in months) from randomisation until the date of progression or death from any cause.
次要结局
- Overall survival (OS) between the two groups(From randomisation to 18 months after last patient randomisation)
- EORTC QLQ-C30 questionnaire(At enrollment, week 16 and week 32 after the start of treatment)
- EORTC QLQ-CR29 questionnaire(At enrollment, week 16 and week 32 after the start of treatment)
- Peritoneal progression free survival (PPFS) between the two groups(From randomisation to 18 months after last patient randomisation)
- Obstruction-free survival (OFS) between the two groups(From randomisation to 18 months after last patient randomisation)
- Histological tumor response(At the end of the 12th course of treatment (week 24))
研究者
研究点 (15)
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