Pilot study to determine the intraTUMORal OsImertinib concentration in patients with peritoneal metastasizeD colorectal cancer (TUMOROID study)

• Conditions: 10017998; Colorectal cancer; colon cancer; 10017991

• Registration Number: NL-OMON51641
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>intratumoral osimertinib concentration in peritoneal metastasis and liver<br /><br>metastasis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Intra- and interpatient variability in intratumoral osimertinib concentrations.<br /><br>Relation between osimertinib concentration in ascites, plasma and healthy<br /><br>tissue vs intratumoral osimertinib concentration. Safety and tolerability of<br /><br>pre-operative osimertinib treatment.</p><br>