Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, open-label, single-arm, phase II study (CRC-PIPAC)

Phase 2

Completed

• Conditions: Unresectable isolated colorectal peritoneal metastases; inoperable peritoneal metastases of large bowel cancer; 10017990; 10027476; 10017998

• Registration Number: NL-OMON49271
• Lead Sponsor: Catharina-ziekenhuis

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

Inclusion Criteria

Eligible patients are adults who have:;* a World Health Organisation (WHO) performance status of *1 and life expectancy >3 months;
* histological or cytological proof of PM of a colorectal or appendiceal carcinoma;
* unresectable disease determined by abdominal computed tomography (CT) and a diagnos-tic laparoscopy or laparotomy;
* adequate organ functions (haemoglobin *5.0 mmol/L, neutrophils *1.5 x 109/L, platelets *100 x 109/L, serum creatinine <1.5 x ULN, creatinine clearance *30 ml/min, and liver trans-aminsases <5 x ULN);
* no symptoms of gastrointestinal obstruction;
* no radiological evidence of systemic metastases;
* no contraindications for oxaliplatin or 5-fluorouracil/leucovorin;
* no contraindications for a laparoscopy;
* no previous PIPAC-procedures;
* written informed consent.;Importantly, enrolment is allowed for patients with an unresected primary tumour (if asymptomatic) and for patients in various lines of palliative treatment, including patients who refuse, have not had, or do not qualify for first-line palliative systemic therapy. All potentially eligible patients are discussed in a multidisplinary team. Enrolled patients need to be informed about the potential consequences of postponing or discontinuing standard palliative treatment by a medical oncologist prior to enrolment.

Exclusion Criteria

Not applicable. See inclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of patients with major toxicity (grade *3 according to the Common<br /><br>Terminology Criteria for Adverse Events v4.0) up to four weeks after the last<br /><br>procedure.</p><br>