PIPAC for peritoneal metastases of colorectal cancer

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

Current inclusion criteria as of 16/01/2019:
1. A World Health Organisation (WHO) performance status of =1 and life expectancy >3 months
2. Histological or cytological proof of PM of a colorectal or appendiceal carcinoma
3. Unresectable disease determined by abdominal computed tomography (CT) and a diagnostic laparoscopy or laparotomy
4. 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 transaminsases <5 x ULN)
5. No symptoms of gastrointestinal obstruction
6. No radiological evidence of systemic metastases
7. No contraindications for oxaliplatin or 5-fluorouracil/leucovorin
8. No contraindications for a laparoscopy
9. No previous PIPAC-procedures
10. 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 multidisciplinary 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.

Previous inclusion criteria:
1. Histologically confirmed unresectable peritoneal metastases of a colorectal or appendiceal carcinoma
2. Asymptomatic presentation (i.e. no disabling malignant ascites or obstructive symptoms)
3. WHO performance score 0-1
4. Written informed consent

Exclusion Criteria

Current exclusion criteria as of 16/01/2019:
See ‘inclusion criteria’

Previous exclusion criteria:
1. Radiological evidence of extra-abdominal metastatic disease
2. Inadequate organ functions (hemoglobin <5.0 mmol/L, absolute neutrophil count <1.5 x 10(9)/L, platelet count <100 x 10(9)/L, serum creatinine >1.5 x ULN, creatinine clearance <30 ml/min, liver transaminases >5 x ULN)
3. Known pregnancy or lactation
4. Known unstable or uncompensated respiratory or cardiac disease
5. Known bleeding diathesis or coagulopathy
6. Serious active infections
7. Any other condition not allowing for a safe laparoscopy or a safe administration of oxaliplatin, 5-fluorouracil, or leucovorin
8. Enrolment in another clinical study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 16/01/2019:<br> The number of patients with major toxicity, defined as grade =3 according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0, up to four weeks after the last ePIPAC-OX.<br><br> Previous primary outcome measure:<br> Major mobidity. Method: Common Terminology Criteria for Adverse Events grade III-V, measured after each PIPAC-procedure up to 4 weeks after the last PIPAC-procedure . Expected timepoint: +/- 16 weeks after inclusion.<br>

Secondary Outcome Measures

Name	Time	Method

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Updated 2/28/2019