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

Completed

• Conditions: NRAS Gene Mutation; BRAF Gene Mutation; Epidermal Growth Factor Receptor Inhibitor; Colorectal Cancer Metastatic; Circulating Tumor DNA; KRAS Gene Mutation
• Interventions: Other: Plasma circulating DNA analysis

• Registration Number: NCT03750175
• Lead Sponsor: Karen-Lise Garm Spindler

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal cancer patients	Plasma circulating DNA analysis	Clinical utility of ctDNA analysis for treatment decision Use of ctDNA for KRAS, NRAS and BRAF testing prior to potential anti-EGFR monoclonal antibody treatment for metastatic colorectal cancer

Primary Outcome Measures

Name	Time	Method
Feasibility of ctDNA analysis for RAS mutation analysis	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 Outcome Measures

Name	Time	Method
OS	3 years	Overall survival rate
Retrospective concordance analysis	By end of study, expected after 3 years	Retrospective comparison of tumor mutation and plasma mutation analysis at baseline
Disease control rate	1 year	Rate of disease control
Resistance mutations	At time of progression, data analysis expected after 3 years	Rate of Ectoderm mutations at time of progression
Lead time	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.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark