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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03750175
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Karen-Lise Garm Spindler, Aarhus University Hospital

Study Description
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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
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
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Study Type : Observational
Actual Enrollment : 49 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 : June 1, 2018
Actual Primary Completion Date : June 1, 2022
Actual Study Completion Date : December 31, 2022
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Retrospective concordance analysis [ Time Frame: By end of study, expected after 3 years ]
    Retrospective comparison of tumor mutation and plasma mutation analysis at baseline

  2. Disease control rate [ Time Frame: 1 year ]
    Rate of disease control

  3. OS [ Time Frame: 3 years ]
    Overall survival rate

  4. Resistance mutations [ Time Frame: At time of progression, data analysis expected after 3 years ]
    Rate of Ectoderm mutations at time of progression

  5. 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.


Biospecimen Retention:   Samples With DNA
Plasma samles for circulating DNA analysis

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750175


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Karen-Lise Garm Spindler
Investigators
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Study Chair: Karen-Lise G Spindler Department of Oncology, AUH, Dk
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Karen-Lise Garm Spindler, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03750175    
Other Study ID Numbers: KFE1713
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases