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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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