PIPAC and Systemic Chemotherapy for Irresectable Colorectal Peritoneal Metastases. (CRC-PIPAC-II)

Recruiting

• Conditions: Colorectal cancer, peritoneal metastases

• Registration Number: NL-OMON28502
• Lead Sponsor: The Catharina Hospital Eindhoven, the Netherlands & the St. Antonius Hospital Nieuwegein, the Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

18 years or older;
- Histologically confirmed PM from a colorectal (including appendix) carcinoma that are not amenable for complete cytoreductive surgery, determined by radiology, laparotomy or laparoscopy;
- WHO performance score of 0-1 and life expectancy >3 months;
- Written informed consent;

Exclusion Criteria

- Radiological evidence of systemic metastatic disease (e.g. liver, lung);
- Symptomatic presentation (e.g. non-deviated obstructive symptoms);
- Histologically confirmed PM from a low grade appendiceal carcinoma (Disseminated Peritoneal Adeno-Mucinosis / Low-grade Appendiceal Mucinous Neoplasm);
- Inadequate organ functions, defined as an Hb of <5.0 mmol/L, an absolute neutrophil count of <1.5 x 10^9/L, platelet count of <100 x 10^9/L, serum creatinine of >1.5 x ULN, creatinine clearance (Cockroft formula) of <30 ml/min, and liver transaminases of >5 x ULN;
- Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, uncompensated cardiac disease, coagulopathy, serious active infections), as determined by the medical oncologist;
- Any contraindication for a laparoscopy, as determined by the surgeon and/or anesthesiologist;
- Previous PIPAC-procedures;
- Previous treatment with palliative systemic chemotherapy (Note: this criterium does not include patients that received systemic chemotherapy in a (neo-)adjuvant setting. (neo-)adjuvant systemic chemotherapy has to be administered >6 months before trial inclusion to be eligible for trial participation).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients with severe toxicity, measured up to 4 weeks after the last cycle of bidirectional therapy consisting of two/three cycles of systemic chemotherapy followed by a laparoscopic ePIPAC-OX procedure.