Status:

UNKNOWN

The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment

Lead Sponsor:

National Health Research Institutes, Taiwan

Collaborating Sponsors:

National Cheng-Kung University Hospital

Kaohsiung Medical University Chung-Ho Memorial Hospital

Conditions:

Colorectal Cancer

Drug Resistance

Eligibility:

All Genders

20-90 years

Brief Summary

To evaluate the emergence of RAS mutation in patients with metastatic colorectal cancer, circulating free DNA will be analyzed using mass spectrometric genotyping in subjects during cetuximab treatmen...

Detailed Description

This is a single arm, non-interventional, uncontrolled, multicenter study in metastatic colorectal cancer patients receiving cetuximab-based infusional 5-FU regimen as 1st line treatment. Patients who...

Eligibility Criteria

Inclusion

  • Patients with histologically proven metastatic colorectal cancer for whom treatment with cetuximab in 1st line setting, is planned as part of routine clinical practice, as per the locally approved label and the best scientific information; the decision to prescribe cetuximab is at the sole discretion of the investigator. The choice of standard chemotherapy regimen for 1st line treatment of colorectal cancer is also at the sole discretion of the Investigator, based upon routine clinical practice.
  • Patients aged 20 years and above.
  • Patients who are molecularly diagnosed as having RAS wild-type mCRC.
  • Patients who are willing to provide blood samples during the study
  • Patients who are willing, and able and give, signed informed consent.

Exclusion

  • Patients having a history of prior exposure to any anti-EGFR therapy.
  • Contra-indications to cetuximab as per locally approved label.

Key Trial Info

Start Date :

January 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2022

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT03401957

Start Date

January 1 2018

End Date

January 1 2022

Last Update

January 17 2018

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

2

National Cheng Kung University Hospital

Tainan, Taiwan

3

Cathay General Hospital

Taipei, Taiwan

4

Taipei Veterans General Hospital

Taipei, Taiwan