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)

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) - CRC-PIPAC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49271

Enrollment

Registered

2019-02-01

Start date

2017-10-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable isolated colorectal peritoneal metastases

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-fluorou

Colorectal Cancer

Intraperitoneal Chemotherapy

Oxaliplatin

Peritoneal Metastases

Eligibility

Age

18 Years to 64 Years

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 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

Exclusion criteria

Exclusion criteria: Not applicable. See inclusion criteria.

Design outcomes

Primary

Measure	Time frame
The number of patients with major toxicity (grade *3 according to the Common Terminology Criteria for Adverse Events v4.0) up to four weeks after the last procedure.	—

Secondary

Measure	Time frame
Secondary outcomes are: * the environmental safety of ePIPAC-OX, based on air concentrations (measured by RPS Analyse, Breda, Netherlands) and surface concentrations (measured by Pharmacy, Cathari-na Hospital, Eindhoven, Netherlands) 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 [120], up to four weeks after the last ePIPAC-OX; organ-specific toxicity, based on bone marrow, liver, and kidney functions measured at dif-ferent time points (Table 1); * major and minor postoperative complications, defined as grade 3 and grade 2 according to Clavien-Dindo [121], 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 af-ter 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 ra-diologists (JN, MLH) blinded to clinical outcomes (classification is not defined a priori); * histopathological tumour response, based on central review of collected peritoneal biop-sies during each ePIPAC-OX, performed by two independent pathologists (e.g. CJRH) blind-ed to clinical outcomes by using the Peritoneal Regression Grading Score [122]; * cytological tumour response, based on collected ascites or peritoneal washing cytology dur-ing each ePIPAC-OX; * macroscopic tumour response, based on PCI and ascites volume during each ePIPAC-OX; * biochemical tumour response, based on tumour markers mea	—

Measure

Time frame

Secondary outcomes are: * the environmental safety of ePIPAC-OX, based on air concentrations (measured by RPS Analyse, Breda, Netherlands) and surface concentrations (measured by Pharmacy, Cathari-na Hospital, Eindhoven, Netherlands) 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 [120], up to four weeks after the last ePIPAC-OX; * organ-specific toxicity, based on bone marrow, liver, and kidney functions measured at dif-ferent time points (Table 1); * major and minor postoperative complications, defined as grade *3 and grade *2 according to Clavien-Dindo [121], 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 af-ter 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 ra-diologists (JN, MLH) blinded to clinical outcomes (classification is not defined a priori); * histopathological tumour response, based on central review of collected peritoneal biop-sies during each ePIPAC-OX, performed by two independent pathologists (e.g. CJRH) blind-ed to clinical outcomes by using the Peritoneal Regression Grading Score [122]; * cytological tumour response, based on collected ascites or peritoneal washing cytology dur-ing each ePIPAC-OX; * macroscopic tumour response, based on PCI and ascites volume during each ePIPAC-OX; * biochemical tumour response, based on tumour markers mea

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)