Repetitive cycles of combination treatment consisting of three cycles of regular chemotherapy followed by a PIPAC-surgery for the treatment of irresectable peritoneal metastases from colorectal cancer: feasibility, safety, tolerability, efficacy.

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. - CRC-PIPAC-II

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002290-63-NL

Enrollment

Registered

2019-10-08

Start date

2020-01-08

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Isolated peritoneal metastases (PM) from colorectal cancer (CRC)

Interventions

Trade Name: Oxaliplatin Product Name: Oxaliplatin Product Code: L01XA03 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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 1.5 x ULN, creatinine clearance (Cockroft formula) 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).

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: From trial inclusion up to 4 weeks after the last PIPAC procedure;Main Objective: To determine the safety of repetitive cycles of bidirectional treatment consisting of systemic chemotherapy followed by ePIPAC with oxaliplatin (92 mg/m2) in patients with isolated PM from CRC;Primary end point(s): The number of patients with CTCAE severe toxicity, measured up to 4 weeks after the last PIPAC procedure; Secondary Objective: - The number of patients with moderate or mild toxicity, measured up to 4 weeks after the last PIPAC procedure. - The technical difficulties with PIPAC technology during each PIPAC procedure - The number of PIPAC procedures in each patient - The number of cycles of bidirectional therapy (each cycle consisting of two/three cycles of systemic chemotherapy followed by a PIPAC procedure) in each patient and reasons for discontinuation. - The number of cycles of systemic chemotherapy completed, the number of dose reductions, and reasons for discontinuation or dose reduction. - The possibility of laparoscopic access during each PIPAC procedure - The volume of ascites during each PIPAC procedure - The PCI during each PIPAC procedure - The operating time of each PIPAC procedure - The blood loss during each PIPAC procedure - The occurrence of intraoperative complications during each PIPAC procedure - The hospital stay after each PIPAC procedure	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: From trial inclusion up to 4 weeks after the last PIPAC procedure;Main Objective: To determine the safety of repetitive cycles of bidirectional treatment consisting of systemic chemotherapy followed by ePIPAC with oxaliplatin (92 mg/m2) in patients with isolated PM from CRC;Primary end point(s): The number of patients with CTCAE severe toxicity, measured up to 4 weeks after the last PIPAC procedure; Secondary Objective: - The number of patients with moderate or mild toxicity, measured up to 4 weeks after the last PIPAC procedure. - The technical difficulties with PIPAC technology during each PIPAC procedure - The number of PIPAC procedures in each patient - The number of cycles of bidirectional therapy (each cycle consisting of two/three cycles of systemic chemotherapy followed by a PIPAC procedure) in each patient and reasons for discontinuation. - The number of cycles of systemic chemotherapy completed, the number of dose reductions, and reasons for discontinuation or dose reduction. - The possibility of laparoscopic access during each PIPAC procedure - The volume of ascites during each PIPAC procedure - The PCI during each PIPAC procedure - The operating time of each PIPAC procedure - The blood loss during each PIPAC procedure - The occurrence of intraoperative complications during each PIPAC procedure - The hospital stay after each PIPAC procedure

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Secondary

Measure	Time frame
Secondary end point(s): - The number of patients with moderate or mild toxicity, measured up to 4 weeks after the last PIPAC procedure. - The technical difficulties with PIPAC technology during each PIPAC procedure - The number of PIPAC procedures in each patient - The number of cycles of bidirectional therapy (each cycle consisting of two/three cycles of systemic chemotherapy followed by a PIPAC procedure) in each patient and reasons for discontinuation. - The number of cycles of systemic chemotherapy completed, the number of dose reductions, and reasons for discontinuation or dose reduction. - The possibility of laparoscopic access during each PIPAC procedure - The volume of ascites during each PIPAC procedure - The PCI during each PIPAC procedure - The operating time of each PIPAC procedure - The blood loss during each PIPAC procedure - The occurrence of intraoperative complications during each PIPAC procedure - The hospital stay after each PIPAC procedure - The number of patients with a readmission during treatment with repetitive bidirectional therapy. - Renal, hepatic, and haematological function and tumour markers at inclusion, before start of each cycle of systemic chemotherapy and before each PIPAC. - The histopathological tumour response of tumour tissue biopsied during each second or third PIPAC procedure. - Quality of life at inclusion, 1 week before each PIPAC and 4 weeks after each PIPAC. - The date of macroscopic intraperitoneal tumour progression - The date of radiologically confirmed systemic tumour progression - The date of death due to any cause, and the reason of death ; Timepoint(s) of evaluation of this end point: - The number of pati	—

Measure

Time frame

Secondary end point(s): - The number of patients with moderate or mild toxicity, measured up to 4 weeks after the last PIPAC procedure. - The technical difficulties with PIPAC technology during each PIPAC procedure - The number of PIPAC procedures in each patient - The number of cycles of bidirectional therapy (each cycle consisting of two/three cycles of systemic chemotherapy followed by a PIPAC procedure) in each patient and reasons for discontinuation. - The number of cycles of systemic chemotherapy completed, the number of dose reductions, and reasons for discontinuation or dose reduction. - The possibility of laparoscopic access during each PIPAC procedure - The volume of ascites during each PIPAC procedure - The PCI during each PIPAC procedure - The operating time of each PIPAC procedure - The blood loss during each PIPAC procedure - The occurrence of intraoperative complications during each PIPAC procedure - The hospital stay after each PIPAC procedure - The number of patients with a readmission during treatment with repetitive bidirectional therapy. - Renal, hepatic, and haematological function and tumour markers at inclusion, before start of each cycle of systemic chemotherapy and before each PIPAC. - The histopathological tumour response of tumour tissue biopsied during each second or third PIPAC procedure. - Quality of life at inclusion, 1 week before each PIPAC and 4 weeks after each PIPAC. - The date of macroscopic intraperitoneal tumour progression - The date of radiologically confirmed systemic tumour progression - The date of death due to any cause, and the reason of death ; Timepoint(s) of evaluation of this end point: - The number of pati

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Countries

Netherlands

Contacts

Public ContactRobin Lurvink

Catharina Hospital

robin.lurvink@catharinaziekenhuis.nl0031402391750

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026