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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

Tracking Information
First Submitted Date September 27, 2018
First Posted Date November 21, 2018
Last Update Posted Date February 3, 2023
Actual Study Start Date June 1, 2018
Actual Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2018)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2018)
  • Retrospective concordance analysis [ Time Frame: By end of study, expected after 3 years ]
    Retrospective comparison of tumor mutation and plasma mutation analysis at baseline
  • Disease control rate [ Time Frame: 1 year ]
    Rate of disease control
  • OS [ Time Frame: 3 years ]
    Overall survival rate
  • Resistance mutations [ Time Frame: At time of progression, data analysis expected after 3 years ]
    Rate of Ectoderm mutations at time of progression
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -
Official Title OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma samles for circulating DNA analysis
Sampling Method Non-Probability Sample
Study Population Patients with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.
Condition
  • Colorectal Cancer Metastatic
  • Circulating Tumor DNA
  • KRAS Gene Mutation
  • NRAS Gene Mutation
  • BRAF Gene Mutation
  • Epidermal Growth Factor Receptor Inhibitor
Intervention Other: Plasma circulating DNA analysis
Clinical utility of ctDNA analysis for treatment decision
Study Groups/Cohorts 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

Intervention: Other: Plasma circulating DNA analysis
Publications * Callesen LB, Sorensen BS, Pallisgaard N, Laugesen IG, Boysen AK, Spindler KG. Total cell-free DNA measurement in metastatic colorectal cancer with a fast and easy direct fluorescent assay. Mol Clin Oncol. 2022 Mar;16(3):64. doi: 10.3892/mco.2022.2497. Epub 2022 Jan 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 2, 2023)		 49
Original Estimated Enrollment
 (submitted: November 20, 2018)		 100
Actual Study Completion Date December 31, 2022
Actual Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03750175
Other Study ID Numbers KFE1713
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Karen-Lise Garm Spindler, Aarhus University Hospital
Original Responsible Party Same as current
Current Study Sponsor Karen-Lise Garm Spindler
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Karen-Lise G Spindler Department of Oncology, AUH, Dk
PRS Account Aarhus University Hospital
Verification Date February 2023