NCT06434896 Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
| NCT ID | NCT06434896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Circulating Tumor DNA |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,320 participants |
| Start Date | 2020-03-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,320 participants in total. It began in 2020-03-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06434896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Circulating Tumor DNA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06434896 currently recruiting?
Yes, NCT06434896 is actively recruiting participants. Contact the research team at plcrcmedocc@umcutrecht.nl for enrollment information.
Where is the NCT06434896 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Alkmaar, Netherlands, Almelo, Netherlands, Almere Stad, Netherlands and 11 additional locations.
Who is sponsoring the NCT06434896 clinical trial?
NCT06434896 is sponsored by UMC Utrecht. The trial plans to enroll 1,320 participants.