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

RecruitingNAAges 18 Years - anyAllUMC Utrecht
NCT06434896 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 direct

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📋 Eligibility rules (as published)
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
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What it tests

  • ctDNA analysis after surgery
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Where

29 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
NKI-AVL
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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