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

February 2, 2023 updated by: Karen-Lise Garm Spindler

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
maximum 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karen-Lise Garm Spindler

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFE1713

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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