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

Sponsor

Karen-Lise Garm Spindler (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03750175

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Metastatic Circulating Tumor DNA KRAS Gene Mutation NRAS Gene Mutation BRAF Gene Mutation Epidermal Growth Factor Receptor Inhibitor	Other: Plasma circulating DNA analysis

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 Design

Study Type:

Observational

Anticipated Enrollment :

59 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Colorectal cancer patients 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	Other: Plasma circulating DNA analysis Clinical utility of ctDNA analysis for treatment decision

Arm

Intervention/Treatment

Colorectal cancer patients

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

Other: Plasma circulating DNA analysis

Clinical utility of ctDNA analysis for treatment decision

Outcome Measures

Primary Outcome Measures

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

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
OS [3 years]
Overall survival rate
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

Karen-Lise Garm Spindler

Investigators

Study Chair: Karen-Lise G Spindler, Department of Oncology, AUH, Dk

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karen-Lise Garm Spindler, Professor, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT03750175

Other Study ID Numbers:

KFE1713

First Posted:

Nov 21, 2018

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Feb 25, 2022