OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - (OPTIPAL-II)

Karen-Lise Garm Spindler

Status: Completed

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

Treatments: Other: Plasma circulating DNA analysis

Study type: Observational

Funder types: Other

Identifiers

NCT03750175

KFE1713

Details and patient eligibility

About

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.

Full 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

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

49 participants in 1 patient group

Colorectal cancer patients

Description:

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

Treatment:

Other: Plasma circulating DNA analysis