The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment
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|ClinicalTrials.gov Identifier: NCT03401957|
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Drug Resistance Mass Spectrometry RAS-RAF Pathway Deregulation||Drug: Cetuximab Diagnostic Test: liquid biopsy|
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 are pathologically diagnosed as metastatic colorectal cancer with RAS wild type genotyping will be recruited in this study. Patients enrolled will be those for whom it is planned to treat their colorectal cancer with a cetuximab-based infusional 5-FU regimen according to the locally approved label. Cetuximab-based treatment is anticipated to be continued until disease progression, intolerable toxic effects, or withdrawal of consent occurs. Blood samples from patients enrolled in this study will be collected before the start of cetuximab-based chemotherapy, and every 3 months during the 1st line treatment with the cetuximab-based regimen. Blood sampling is also required at 2-3 weeks after disease progression following cetuximab treatment and after disease progression on 2nd line treatment. The blood samples will be sent to a central laboratory at the Taipei Institute of Pathology and evaluated for RAS genotype, using MassARRAY technique. The objectives of this study are described as follows.
To observe the percentage of detected RAS mutations (circulating DNA) during 1st line cetuximab exposure in Taiwanese patients.
- To observe the time to onset of detected RAS mutation in circulating DNA.
- To observe the quantification mutation load change under treatment.
- To evaluate clinical response and resection rate of metastases with 1st line cetuximab exposure.
- To evaluate treatment duration with 1st line cetuximab.
- 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).
- To calculate total 1st line cetuximab exposure dosage.
- To investigate correlation between the irinotecan or oxaliplatin dosage and acquired resistance.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||18 Months|
|Official Title:||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|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
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-based infusional 5-FU regimen as the 1st line treatment.
Other Name: erbitux
Diagnostic Test: liquid biopsy
The blood samples taken from subjects will be evaluated for RAS genotype using MassARRAY technique.
- Percentage of detected circulating DNA RAS mutations during 1st line cetuximab exposure. [ Time Frame: 9 months ]Percentage of detected RAS mutations during cetuximab treatment.
- Time to onset of newly detected circulating DNA RAS mutation. [ Time Frame: 9 months ]Time duration between the start of cetuximab treatment and newly detection of RAS mutation.
- Mutation load (percentage of detected mutated alleles) until disease progression. [ Time Frame: 9 months ]Percentage of detected mutated alleles at disease progression.
- Percentage of detected RAS mutations at the time of progression. [ Time Frame: 9 months ]Percentage of detected RAS mutations at the time of progression.
- Clinical response rate by the investigator's judgement based on RECIST criteria. [ Time Frame: 9 months ]Response rate of tumor after cetuximab treatment.
- Resection rate of liver or lung metastases. [ Time Frame: 9 months ]Resection rates of metastases after cetuximab treatment.
- Duration of treatment with cetuximab in 1st line treatment. [ Time Frame: 9 months ]Time duration of cetuximab as the 1st line treatment.
- Total accumulated dosage of cetuximab in 1st line treatment. [ Time Frame: 9 months ]Total accumulated dosage of cetuximab in 1st line treatment.
- Progression-free survival from start of 1st line treatment with cetuximab. [ Time Frame: 9 months ]The time duration of subjects between the inclusion in the study and disease progression.
- Overall survival from the start of 1st line treatment with cetuximab. [ Time Frame: 24 months ]The time duration of subjects between the inclusion in the study and death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401957
|Contact: Shang Hung Chen, M.D.||+886-6-7000123 ext firstname.lastname@example.org|
|Kaohsiung Medical University Chung-Ho Memorial Hospital||Recruiting|
|Contact: Jaw-Yuan Wang, M.D. email@example.com|
|National Cheng Kung University Hospital||Recruiting|
|Contact: Shang Hung Chen, M.D. +886-6-7000123 ext 65113 firstname.lastname@example.org|
|Cathay General Hospital||Not yet recruiting|
|Contact: Yung-Chuan Sung, M.D. email@example.com|
|Taipei Veterans General Hospital||Recruiting|
|Contact: Jeng-Kai Jiang, M.D. firstname.lastname@example.org|
|Principal Investigator:||Li-Tzong Chen, M.D.||National Institute of Cancer Research, National Health Research Institutes|