Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Launched by UMC UTRECHT · May 23, 2024
Trial Information
Current as of March 14, 2025
Recruiting
Keywords
ClinConnect Summary
The MEDOCC-CrEATE Trial is a research study that focuses on patients with stage II colon cancer who are not typically recommended for additional chemotherapy after surgery. This trial is looking at whether testing the blood for a specific type of cancer marker called circulating tumor DNA (ctDNA) can help doctors decide who might benefit from chemotherapy. Patients in this study will be randomly assigned to one of two groups: one group will have their ctDNA tested, and if detectable, they will receive chemotherapy for three months. The other group will follow the standard approach, which means they will receive regular follow-up care without immediate chemotherapy.
To be eligible for this trial, participants need to be at least 18 years old, have confirmed stage II colon cancer, and provide consent for additional blood tests and tissue collection for research. They should also be healthy enough to undergo chemotherapy if needed. Importantly, those who already need chemotherapy or have had other serious cancers recently are not eligible. Participants will not only contribute to important research but also receive careful monitoring and follow-up from their healthcare team throughout the study.
Gender
ALL
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
About Umc Utrecht
UMC Utrecht is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research and high-quality patient care. As a prominent sponsor of clinical trials, UMC Utrecht leverages its extensive expertise in translational medicine and collaboration with various stakeholders to advance medical knowledge and improve therapeutic outcomes. The institution emphasizes ethical conduct and rigorous scientific standards, ensuring that all research activities contribute meaningfully to the global healthcare landscape. Through its robust clinical trial infrastructure, UMC Utrecht plays a vital role in facilitating the development of new treatments and enhancing patient wellbeing.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Deventer, , Netherlands
Ede, , Netherlands
Nijmegen, , Netherlands
Veldhoven, , Netherlands
Almelo, , Netherlands
Breda, , Netherlands
Utrecht, , Netherlands
Utrecht, , Netherlands
Arnhem, , Netherlands
Delft, , Netherlands
Nieuwegein, , Netherlands
Almere, , Netherlands
Harderwijk, , Netherlands
Venlo, , Netherlands
Roosendaal, , Netherlands
Maastricht, , Netherlands
Weert, , Netherlands
Goes, , Netherlands
Haarlem, , Netherlands
Rotterdam, , Netherlands
Alkmaar, , Netherlands
Amersfoort, Utrecht, Netherlands
Dordrecht, , Netherlands
Uden, , Netherlands
Den Haag, , Netherlands
'S Hertogenbosch, , Netherlands
Gorinchem, , Netherlands
Middelharnis, , Netherlands
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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