Colorectal Neoplasms Clinical Trial
Official title:
Repetitive Electrostatic Pressurised Intraperitoneal Aerosol Chemotherapy With Oxaliplatin (ePIPAC-OX) as a Palliative Monotherapy for Isolated Unresectable Colorectal Peritoneal Metastases: Protocol of a Multicentre, Open-label, Single-arm, Phase II Study (CRC-PIPAC)
This is multicentre, open-label, single-arm phase II study that investigates the feasibility, safety, tolerability, preliminary efficacy, costs, and pharmacokinetics or repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC-OX) as a palliative monotherapy for patients with isolated unresectable colorectal peritoneal metastases.
Rationale: repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with
oxaliplatin (ePIPAC-OX) is offered as a palliative treatment option for patients with
isolated unresectable colorectal peritoneal metastases (PM) in several centres worldwide.
However, little is known about its feasibility, safety, tolerability, efficacy, costs, and
pharmacokinetics in this setting.
Objectives: to prospectively explore the feasibility, safety, tolerability, preliminary
efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative
monotherapy for isolated unresectable colorectal PM under controlled circumstances.
Study design: multicentre, open-label, single-arm, phase II study.
Setting: two Dutch tertiary referral hospitals for the surgical treatment of colorectal PM.
Study population: adults who have a World Health Organisation (WHO) performance status of 0
or 1, adequate organ functions, histologically or cytologically confirmed unresectable PM of
a colorectal or appendiceal carcinoma, no systemic metastases, no symptoms of
gastrointestinal obstruction, no contraindications for the planned intervention, and no
previous pressurised intraperitoneal aerosol chemotherapy (PIPAC).
Intervention: 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-fluorouracil (400 mg/m2 BSA) every six weeks. Four
weeks after each procedure, patients undergo clinical, radiological, and biochemical
evaluation. ePIPAC-OX is repeated until clinical, radiological, or macroscopic disease
progression, after which standard palliative treatment is (re)introduced.
Outcomes: the primary outcome is 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 outcomes are the environmental safety of ePIPAC-OX,
procedure-related characteristics, the number of procedures in each patient and reasons for
discontinuation, minor toxicity, organ-specific toxicity, postoperative complications,
hospital stay, readmissions, quality of life, costs, progression-free survival, overall
survival, and the radiological, histopathological, cytological, biochemical, and macroscopic
tumour response. Atomic absorption spectrophotometry is used to measure concentrations of
oxaliplatin in plasma, plasma ultrafiltrate, urine, ascites, PM, and normal peritoneum during
and after ePIPAC-OX.
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