The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment
A Non-interventional Uncontrolled Multicenter Study to Investigate the Emergence of RAS Resistance Mutations in RAS Wild Type mCRC Patients Receiving First Line Cetuximab Treatment
1 other identifier
observational
120
1 country
4
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 treatment. The hypothesis of this study is that acquired RAS mutation is responsible for the resistance to cetuximab treatment in wild-type colorectal cancer. The usefulness of liquid biopsy to monitor dynamic genetic alterations in colorectal cancer during treatment will also be investigated in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 10, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJanuary 17, 2018
January 1, 2018
4 years
January 10, 2018
January 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of detected circulating DNA RAS mutations during 1st line cetuximab exposure.
Percentage of detected RAS mutations during cetuximab treatment.
9 months
Secondary Outcomes (9)
Time to onset of newly detected circulating DNA RAS mutation.
9 months
Mutation load (percentage of detected mutated alleles) until disease progression.
9 months
Percentage of detected RAS mutations at the time of progression.
9 months
Clinical response rate by the investigator's judgement based on RECIST criteria.
9 months
Resection rate of liver or lung metastases.
9 months
- +4 more secondary outcomes
Study Arms (1)
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.
Interventions
Cetuximab-based infusional 5-FU regimen as the 1st line treatment.
The blood samples taken from subjects will be evaluated for RAS genotype using MassARRAY technique.
Eligibility Criteria
Patients with RAS wild-type metastatic colorectal cancer receiving cetuximab-based regimen (5-FU containing) as the 1st line treatment.
You may qualify if:
- 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.
You may not qualify if:
- Patients having a history of prior exposure to any anti-EGFR therapy.
- Contra-indications to cetuximab as per locally approved label.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Health Research Institutes, Taiwanlead
- National Cheng-Kung University Hospitalcollaborator
- Kaohsiung Medical University Chung-Ho Memorial Hospitalcollaborator
- Taipei Veterans General Hospital, Taiwancollaborator
- Cathay General Hospitalcollaborator
Study Sites (4)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Cathay General Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Related Publications (2)
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.
PMID: 37488448DERIVEDChen 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.
PMID: 31253124DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Tzong Chen, M.D.
National Institute of Cancer Research, National Health Research Institutes
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2018
First Posted
January 17, 2018
Study Start
January 1, 2018
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
January 17, 2018
Record last verified: 2018-01