Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial (CrEATE)

May 7, 2026 updated by: Miriam Koopman, UMC Utrecht

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).

Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1320

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Recruiting
        • Jeroen Bosch Ziekenhuis
        • Contact:
          • M.L. Wumkes
      • Alkmaar, Netherlands
        • Recruiting
        • Noordwest ziekenhuisgroep
        • Contact:
          • M.P. Hendriks
      • Almelo, Netherlands
        • Recruiting
        • Ziekenhuisgroep Twente
        • Contact:
          • R. Hoekstra
      • Almere Stad, Netherlands
        • Recruiting
        • Flevoziekenhuis
        • Contact:
          • J.D.W. van der Bilt
      • Amersfoort, Netherlands
        • Recruiting
        • Meander Medisch Centrum
        • Contact:
          • J.M. van Dodewaard
      • Amsterdam, Netherlands
        • Recruiting
        • NKI-AvL
        • Contact:
          • K. Bolhuis
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate
        • Contact:
          • I. Werter
      • Breda, Netherlands
        • Recruiting
        • Amphia Ziekenhuis
        • Contact:
          • M. Streppel
      • Delft, Netherlands
        • Recruiting
        • Reinier de Graaf Gasthuis
        • Contact:
          • A.J. Verschoor
      • Deventer, Netherlands
        • Recruiting
        • Deventer Ziekenhuis
        • Contact:
          • L.W. Kessels
      • Dordrecht, Netherlands
        • Recruiting
        • Albert Schweizer Ziekenhuis
        • Contact:
          • M. Vidakovic
      • Ede, Netherlands
        • Recruiting
        • Ziekenhuis Gelderse Vallei
        • Contact:
          • M. Verstappen
      • Goes, Netherlands
        • Recruiting
        • Admiraal de Ruyter Ziekenhuis
        • Contact:
          • H.K. van Halteren
      • Gorinchem, Netherlands
        • Recruiting
        • Rivas
        • Contact:
          • M.A. Davidis
      • Haarlem, Netherlands
        • Recruiting
        • Spaarne Gasthuis
        • Contact:
          • H.B.A.C. Stockmann
      • Harderwijk, Netherlands
        • Recruiting
        • Ziekenhuis St. Jansdal
        • Contact:
          • A.P. Schouten van der Velden
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht UMC
        • Contact:
          • L.B.J. Valkenburg
      • Middelharnis, Netherlands
        • Recruiting
        • Van Weel-Bethesda Ziekenhuis
        • Contact:
          • A. Dietvorst
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Ziekenhuis
        • Contact:
          • M. Los
      • Nijmegen, Netherlands
        • Recruiting
        • Canisius Wilhelmina Ziekenhuis
        • Contact:
          • J. Janssen
      • Roosendaal, Netherlands
        • Recruiting
        • Bravis Ziekenhuis
        • Contact:
          • S. Boudewijns
      • Rotterdam, Netherlands
        • Recruiting
        • Ikazia Ziekenhuis
        • Contact:
          • F.E. de Jongh
      • The Hague, Netherlands
        • Recruiting
        • Haaglanden MC
        • Contact:
          • F.J.F. Jeurissen
      • Uden, Netherlands
        • Recruiting
        • Bernhoven
        • Contact:
          • J. van Extel
      • Utrecht, Netherlands
        • Recruiting
        • UMC Utrecht
        • Contact:
          • Miriam Koopman
      • Utrecht, Netherlands
        • Recruiting
        • Diakonessenhuis
        • Contact:
          • L. van Leeuwen
      • Veldhoven, Netherlands
        • Recruiting
        • Maxima Medisch Centrum
        • Contact:
          • L.H.J Simkens
      • Venlo, Netherlands
        • Recruiting
        • Viecuri Medisch Centrum
        • Contact:
          • J. Konsten
      • Weert, Netherlands
        • Recruiting
        • St. Jans Gasthuis
        • Contact:
          • N.A.J.B. Peters

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years

  • Informed consent for PLCRC with specific consent for:

    • additional blood withdrawals
    • collection and use of tissue for scientific research
    • invitation for future (experimental) research within the cohort, including TwiCs studies
  • Inclusion in observational PLCRC -MEDOCC substudy
  • Histological confirmed stage II colon cancer
  • Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician

Exclusion Criteria:

  • Indication for adjuvant chemotherapy according to treating physician
  • Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
  • Incomplete primary tumor resection (R1 or R2 resection)
  • Contra-indication for fluoropyrimidines or oxaliplatin
  • Pregnancy

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ctDNA-based treatment group
Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.
Other: ctDNA analysis after surgery
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
No Intervention: Standard of care group
The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
Time Frame: 8-12 weeks after surgery
8-12 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rate
Time Frame: 2 and 5 years after surgery
Proportion of patients that will experience disease recurrence
2 and 5 years after surgery
Disease Free Survival rate
Time Frame: 2 and 5 years after surgery
Proportion of patients that are alive and free of disease
2 and 5 years after surgery
Disease-related Overall Survival rate
Time Frame: 5 years after surgery
Proportion of patients that are alive
5 years after surgery
Time to Recurrence
Time Frame: From date of randomization until the date of recurrence, assessed up to 5 years.
From date of randomization until the date of recurrence, assessed up to 5 years.
Quality of Life after treatment
Time Frame: 10 years

Quality of Life (QoL) will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC.

Comparison of QoL of the ctDNA positive patients in both study arms will be done using repeated measurements methods, including ACT as factor. QoL will also be analysed for the whole population in both arms of the study. Treatment differences at each QoL assessment time point will be compared by means of the Wilcoxon Rank Sum Test.
10 years
Cost-effectiveness of the ctDNA-based treatment
Time Frame: 5 years after diagnosis
The cost-effectiveness analysis will be carried out from a societal perspective, including both direct health care costs as well as indirect costs from productivity loss. The health outcome measure in the cost-effectiveness analysis will be the total quality adjusted life years (QALY) per group.
5 years after diagnosis

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Collaborators

The Netherlands Cancer Institute
Personal Genome Diagnostics

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)

March 5, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL71881.041.19

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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