The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment
NCT ID: NCT03401957
Last Updated: 2018-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2018-01-31
2022-01-31
Brief Summary
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Detailed Description
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Primary objective:
To observe the percentage of detected RAS mutations (circulating DNA) during 1st line cetuximab exposure in Taiwanese patients.
Secondary objective:
1. To observe the time to onset of detected RAS mutation in circulating DNA.
2. To observe the quantification mutation load change under treatment.
3. To evaluate clinical response and resection rate of metastases with 1st line cetuximab exposure.
4. To evaluate treatment duration with 1st line cetuximab.
5. To investigate the correlation between the occurrence and levels of acquired RAS mutations post-cetuximab treatment and clinical outcomes (progression free survival and overall survival).
6. To calculate total 1st line cetuximab exposure dosage.
7. To investigate correlation between the irinotecan or oxaliplatin dosage and acquired resistance.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RAS wild-type colorectal cancer
RAS mutation of patients who are pathologically diagnosed as metastatic colorectal cancer with RAS wild type genotyping will be evaluated using liquid biopsy during cetuximab treatment.
Cetuximab
Cetuximab-based infusional 5-FU regimen as the 1st line treatment.
liquid biopsy
The blood samples taken from subjects will be evaluated for RAS genotype using MassARRAY technique.
Interventions
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Cetuximab
Cetuximab-based infusional 5-FU regimen as the 1st line treatment.
liquid biopsy
The blood samples taken from subjects will be evaluated for RAS genotype using MassARRAY technique.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients aged 20 years and above.
3. Patients who are molecularly diagnosed as having RAS wild-type mCRC.
4. Patients who are willing to provide blood samples during the study
5. Patients who are willing, and able and give, signed informed consent.
Exclusion Criteria
2. Contra-indications to cetuximab as per locally approved label.
20 Years
90 Years
ALL
No
Sponsors
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National Cheng-Kung University Hospital
OTHER
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Cathay General Hospital
OTHER
National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Li-Tzong Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cancer Research, National Health Research Institutes
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Tsai HL, Lin CC, Sung YC, Chen SH, Chen LT, Jiang JK, Wang JY. The emergence of RAS mutations in patients with RAS wild-type mCRC receiving cetuximab as first-line treatment: a noninterventional, uncontrolled multicenter study. Br J Cancer. 2023 Oct;129(6):947-955. doi: 10.1038/s41416-023-02366-z. Epub 2023 Jul 24.
Chen SH, Tsai HL, Jiang JK, Sung YC, Huang CW, Yeh YM, Chen LT, Wang JY. Emergence of RAS mutations in patients with metastatic colorectal cancer receiving cetuximab-based treatment: a study protocol. BMC Cancer. 2019 Jun 28;19(1):640. doi: 10.1186/s12885-019-5826-7.
Other Identifiers
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EC1060904
Identifier Type: -
Identifier Source: org_study_id
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