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Completed

NCT Number: NCT03750175

OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -

The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.

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Key information

Conditions

Colorectal Cancer Metastatic BRAF Gene Mutation Circulating Tumor DNA Epidermal Growth Factor Receptor Inhibitor KRAS Gene Mutation NRAS Gene Mutation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy

Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histopathologically verified metastatic colorectal cancer
  • Indication for systemic palliative treatment with standard Anti-EGFR monoclonal antibodies
  • Fit for therapy with EGFR inhibition
  • Consent to treatment and sampling
  • Measureable disease according to RECIST v 1.1
  • Age ≥ 18

Exclusion criteria

  • PS > 2
  • Significant other cancer disease within 5 years of inclusion
  • Conditions precluding sampling during therapy and treatment breaks.

Treatment and study plan

Plasma circulating DNA analysis

Other

Clinical utility of ctDNA analysis for treatment decision

Primary outcomes

  1. Feasibility of ctDNA analysis for RAS mutation analysis

    Time frame: maximum 7 days

    Feasibility measures

    Identification of wildtype or mutated status and results delivered to clinicians

    • Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days
    • Detailed mutation type characterization is provided retrospectively.

    Failure parameters

    • Quality of samples; PB > 5%, CPP1 major loss < 10%
    • Transportation > 3 week days
    • Analysis > 3 working days
    • Total results delivered > 7 days.

Secondary outcomes

  1. Retrospective concordance analysis

    Time frame: By end of study, expected after 3 years

    Retrospective comparison of tumor mutation and plasma mutation analysis at baseline

  2. Disease control rate

    Time frame: 1 year

    Rate of disease control

  3. OS

    Time frame: 3 years

    Overall survival rate

  4. Resistance mutations

    Time frame: At time of progression, data analysis expected after 3 years

    Rate of Ectoderm mutations at time of progression

  5. Lead time

    Time frame: At time of progression, data analysis expected after 3 years

    Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA.

Sponsors and collaborators

Lead sponsor

Karen-Lise Garm Spindler

Other

Registry information

Official study title

OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions

Acronym: OPTIPAL-II

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2018
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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