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

Colorectal Cancer Metastatic Clinical Trial

— OPTIPAL-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750175
• Other study ID #: KFE1713
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 31, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Plasma circulating DNA analysis
Clinical utility of ctDNA analysis for treatment decision

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Karen-Lise Garm Spindler

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of ctDNA analysis for RAS mutation analysis	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.	maximum 7 days
Secondary	Retrospective concordance analysis	Retrospective comparison of tumor mutation and plasma mutation analysis at baseline	By end of study, expected after 3 years
Secondary	Disease control rate	Rate of disease control	1 year
Secondary	OS	Overall survival rate	3 years
Secondary	Resistance mutations	Rate of Ectoderm mutations at time of progression	At time of progression, data analysis expected after 3 years
Secondary	Lead time	Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA.	At time of progression, data analysis expected after 3 years