Colorectal Neoplasms
Conditions
Interventions
Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled ePIPAC-OX (92 mg/m2 body-surface area [BSA]) with intravenous leucovorin (20 mg/m2 BSA) and bolus 5-fluoroura
Sponsors
Catharina Hospital, Eindhoven, Netherlands
Eligibility
Inclusion criteria
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 diagnostic 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 transaminsases <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
Exclusion criteria: See inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are:  the environmental safety of ePIPAC-OX, based on air concentrations and surface concentrations of oxaliplatin during the first three procedures, measured by atomic absorption spectrophotometry;  procedure-related characteristics of ePIPAC-OX (e.g. laparoscopic access, intraoperative complications, amount of adhesions, technical difficulties, operating time);  the number of procedures in each patient and reasons for discontinuation;  minor toxicity, defined as grade ≤2 according to CTCAE v4.0, up to four weeks after the last ePIPAC-OX;  organ-specific toxicity, based on bone marrow, liver, and kidney functions measured at baseline, each postoperative day, and four weeks after each ePIPAC-OX;  major and minor postoperative complications, defined as grade ≥3 and grade ≤2 according to Clavien-Dindo, respectively, up to four weeks after the last ePIPAC-OX;  hospital stay, defined as the number of days between ePIPAC-OX and initial discharge;  readmissions, defined as any hospital admission after initial discharge, up to four weeks after the last ePIPAC-OX;  radiological tumour response, based on central review of thoracoabdominal CT and DW-MRI at baseline and four weeks after each ePIPAC-OX, performed by two independent radiologists blinded to clinical outcomes (classification is not defined a priori);  histopathological tumour response, based on central review of collected peritoneal biopsies during each ePIPAC-OX, performed by two independent pathologists blinded to clinical outcomes by using the Peritoneal Regression Grading Score;  cytological tumour response, based on collected ascites or peritoneal washing cytology during each ePIPAC-OX;  macroscopic tumour response, based on PCI and ascites volume during each ePIPAC-OX;  biochemical tumour response, based on tumour markers measured at different time poin | — |
Contacts
Public ContactKoen Rovers
PO Box 1350
Outcome results
None listed