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NCT Number: NCT06434896

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

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.

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Key information

Conditions

Circulating Tumor DNA Colon Cancer Stage II Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ctDNA analysis after surgery

Other

ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.

Primary outcomes

  1. Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.

    Time frame: 8-12 weeks after surgery

Secondary outcomes

  1. Recurrence Rate

    Time frame: 2 and 5 years after surgery

    Proportion of patients that will experience disease recurrence

  2. Disease Free Survival rate

    Time frame: 2 and 5 years after surgery

    Proportion of patients that are alive and free of disease

  3. Disease-related Overall Survival rate

    Time frame: 5 years after surgery

    Proportion of patients that are alive

  4. Time to Recurrence

    Time frame: From date of randomization until the date of recurrence, assessed up to 5 years.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Miriam Koopman, Prof. dr.

CONTACT

[email protected]

+316 46 91 95 66

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Personal Genome Diagnostics
  • The Netherlands Cancer Institute

Registry information

Acronym: CrEATE

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 30, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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