Using blood tests to guide chemotherapy in stage II colon cancer patients
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
This study tests if using blood tests to check for tumor DNA can help doctors decide if stage II colon cancer patients need extra chemotherapy after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 29 sites ('s-Hertogenbosch and 28 other locations) |
| Trial ID | NCT06434896 on ClinicalTrials.gov |
What this trial studies
This study involves patients with stage II colon cancer who are part of the Dutch ColoRectal Cancer cohort. Participants will be randomly assigned to either a ctDNA-based treatment group or a standard care group. Blood samples will be collected before and after surgery to analyze circulating tumor DNA (ctDNA) levels, which will help determine the need for adjuvant chemotherapy. The goal is to assess whether ctDNA analysis can improve treatment decisions and outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage II colon cancer who have provided informed consent for additional blood withdrawals and biobanking.
Not a fit: Patients who are already indicated for adjuvant chemotherapy or have contraindications for the treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans and potentially better outcomes for patients with stage II colon cancer.
How similar studies have performed: Other studies have shown promise in using ctDNA for treatment decision-making, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
's-Hertogenbosch and 28 other locations
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (Recruiting)
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (Recruiting)
- Ziekenhuisgroep Twente — Almelo, Netherlands (Recruiting)
- Flevoziekenhuis — Almere Stad, Netherlands (Recruiting)
- Meander Medisch Centrum — Amersfoort, Netherlands (Recruiting)
- Nki-Avl — Amsterdam, Netherlands (Recruiting)
- Rijnstate — Arnhem, Netherlands (Recruiting)
- Amphia Ziekenhuis — Breda, Netherlands (Recruiting)
- Reinier de Graaf Gasthuis — Delft, Netherlands (Recruiting)
- Deventer Ziekenhuis — Deventer, Netherlands (Recruiting)
- Albert Schweizer Ziekenhuis — Dordrecht, Netherlands (Recruiting)
- Ziekenhuis Gelderse Vallei — Ede, Netherlands (Recruiting)
- Admiraal de Ruyter Ziekenhuis — Goes, Netherlands (Recruiting)
- Rivas — Gorinchem, Netherlands (Recruiting)
- Spaarne Gasthuis — Haarlem, Netherlands (Recruiting)
- Ziekenhuis St. Jansdal — Harderwijk, Netherlands (Recruiting)
- Maastricht UMC — Maastricht, Netherlands (Recruiting)
- Van Weel-Bethesda Ziekenhuis — Middelharnis, Netherlands (Recruiting)
- St. Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (Recruiting)
- Bravis Ziekenhuis — Roosendaal, Netherlands (Recruiting)
- Ikazia Ziekenhuis — Rotterdam, Netherlands (Recruiting)
- Haaglanden MC — The Hague, Netherlands (Recruiting)
- Bernhoven — Uden, Netherlands (Recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
- Maxima Medisch Centrum — Veldhoven, Netherlands (Recruiting)
- VieCuri Medisch Centrum — Venlo, Netherlands (Recruiting)
- St. Jans Gasthuis — Weert, Netherlands (Recruiting)
Study contacts
- Study coordinator: Miriam Koopman, Prof. dr.
- Email: plcrcmedocc@umcutrecht.nl
- Phone: +316 46 91 95 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.