Status:
COMPLETED
PIPAC for Peritoneal Metastases of Colorectal Cancer
Lead Sponsor:
Koen Rovers
Conditions:
Colorectal Neoplasms
Peritoneal Neoplasms
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This is multicentre, open-label, single-arm phase II study that investigates the feasibility, safety, tolerability, preliminary efficacy, costs, and pharmacokinetics or repetitive electrostatic pressu...
Detailed Description
Rationale: repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) is offered as a palliative treatment option for patients with isolated unresectable co...
Eligibility Criteria
Inclusion
- Eligible patients are adults who have:
- a World Health Organisation (WHO) performance status of ≤1;
- 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 transaminases \<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.
- Enrolled patients are excluded from the analyses in case they did not receive a first ePIPAC-OX, e.g.:
- due to systemic metastases on baseline thoracoabdominal CT, or;
- due to non-access during first ePIPAC-OX, or;
- due to resectable disease during first ePIPAC-OX.
- 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 by a multidisciplinary team. Enrolled patients are informed about the potential consequences of postponing or discontinuing standard palliative treatment by a medical oncologist prior to enrolment.
Exclusion
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03246321
Start Date
October 1 2017
End Date
October 1 2019
Last Update
October 15 2019
Active Locations (2)
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1
Catharina Hospital
Eindhoven, Netherlands
2
St. Antonius Hospital
Nieuwegein, Netherlands