Bidirectional treatment consisting of repetitive laparoscopic electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) and systemic intravenous chemotherapy for isolated unresectable colorectal peritoneal metastases: feasibility, safety, tolerability, and preliminary efficacy.

Phase 2

Completed

• Conditions: Colorectal Cancer with Metastases in the Peritoneum; Colorectal Peritoneal Carcinomatosis; 10017990; 10027476; 10017998

• Registration Number: NL-OMON50015
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

- 18 years or older
- Histologically confirmed PM from a colorectal (including appendiceal)
carcinoma that are not amenable for complete cytoreductive surgery, as
determined by laparotomy, laparoscopy or radiology.
- WHO performance score of 0-1
- 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. Patients treated with (neo-)adjuvant chemotherapy are
able to enrol in the study if this treatment was finished >6 months before
trial enrolment).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major toxicity, defined as grade >2 according to the Common Terminology<br /><br>Criteria for Adverse Events v4.0, and measured up to four weeks after the last<br /><br>PIPAC procedure. </p><br>