Isolated unresectable colorectal peritoneal metastases
Conditions
Interventions
Trade Name: Oxaliplatin Accord
Product Name: Oxaliplatin
Product Code: L01XA03
Pharmaceutical Form: Solution for injection
Trade Name:
Sponsors
Catharina Ziekenhuis
Eligibility
Sex/Gender
All
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 =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: See inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the safety of repetitive ePIPAC-OX as a palliative monotherapy for patients with isolated unresectable colorectal peritoneal metastases (PM).;Secondary Objective: To explore the feasibility, tolerability, preliminary efficacy, costs, and pharmacokinetics of repetitive ePIPAC-OX as a palliative monotherapy for patients with isolated unresectable colorectal PM.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: See E.5.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: See E.5.2.; Secondary end point(s): 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 dif-ferent time points (Table 1 in protocol); ? 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 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 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 blind-ed to clinical outcomes by using the Peritoneal Regression Grading Score; ? cytological tumour response, based on collected ascites or peritoneal washing cytology dur-ing each ePIPAC-OX; ? ma | — |
Countries
Netherlands
Contacts
Public ContactKoen Rovers
Catharina Ziekenhuis
Outcome results
None listed