NL-OMON51641
Not yet recruiting
Not Applicable
Pilot study to determine the intraTUMORal OsImertinib concentration in patients with peritoneal metastasizeD colorectal cancer (TUMOROID study) - TUMOROID study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal cancer
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 10
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- Not fit to undergo surgery
- •\- The use of concomitant drugs that interact with osimertinib according to the
- •\- 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
Outcomes
Primary Outcomes
Not specified
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