Colorectal cancer
Conditions
Interventions
Patients of both groups will be treated with osimertinib in the registered
dosing schedule (80mg OD) for a period of 1 week prior to CRC-HIPEC (group 1)
or liver resection (group 2). Five patients w
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosed with PM of CRC and candidate for CRS-HIPEC (GROUP 1) - Diagnosed with liver metastasis of CRC and candidate for primary resection of at least one liver metastasis (GROUP 2) - 18 years or older - WHO performance status 0 or 1 - Adequate haematologic and organ function - Written informed consent - Able to swallow oral medication
Exclusion criteria
Exclusion criteria: - Not fit to undergo surgery - The use of concomitant drugs that interact with osimertinib according to the SPC - An active contraindication for the use of osimertinib - Mean resting corrected QT interval (QTc) > 470 msec at screening - Medical history of interstitial lung disease - Medical history of any skin disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intratumoral osimertinib concentration in peritoneal metastasis and liver metastasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Intra- and interpatient variability in intratumoral osimertinib concentrations. Relation between osimertinib concentration in ascites, plasma and healthy tissue vs intratumoral osimertinib concentration. Safety and tolerability of pre-operative osimertinib treatment. | — |
Countries
Netherlands
Outcome results
None listed