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

Last updated: January 10, 2018
Sponsor: National Health Research Institutes, Taiwan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT03401957
EC1060904
  • Ages 20-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with histologically proven metastatic colorectal cancer for whom treatmentwith 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 toprescribe cetuximab is at the sole discretion of the investigator. The choice ofstandard chemotherapy regimen for 1st line treatment of colorectal cancer is also atthe sole discretion of the Investigator, based upon routine clinical practice.

  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

Exclusion Criteria:

  1. Patients having a history of prior exposure to any anti-EGFR therapy.

  2. Contra-indications to cetuximab as per locally approved label.

Study Design

Total Participants: 120
Study Start date:
January 01, 2018
Estimated Completion Date:
January 31, 2022

Study 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 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.

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.

Connect with a study center

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung,
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Active - Recruiting

  • Cathay General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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