Actively Recruiting
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Led by UMC Utrecht · Updated on 2026-05-12
1320
Participants Needed
29
Research Sites
N/A
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
P
Personal Genome Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with non-metastatic stage II colon cancer who are part of the Dutch ColoRectal Cancer cohort (PLCRC) and who consented to additional blood samples. The study aims to evaluate how many patients with detectable circulating tumor DNA (ctDNA) after surgery begin adjuvant chemotherapy. This observational and interventional trial includes patients who do not have a standard indication for chemotherapy and involves a randomized design to compare ctDNA-guided treatment with standard care. Patients are randomly assigned to one of two groups: the ctDNA-based treatment group or the standard care group. In the ctDNA group, blood samples taken after surgery are analyzed for ctDNA. Those with detectable ctDNA are offered 3 months of adjuvant chemotherapy using CAPOX (a combination of fluoropyrimidine and oxaliplatin). Patients without detectable ctDNA receive routine follow-up care. The standard care group receives routine follow-up without knowledge of their ctDNA results. Participants will have blood collected before surgery, after surgery, and during follow-up. Researchers will monitor who starts chemotherapy within 8 to 12 weeks after surgery and will track recurrence rates, disease-free survival, overall survival, time to recurrence, quality of life, and cost-effectiveness over several years. Follow-up assessments occur up to 10 years, allowing detailed long-term evaluation of treatment impact and patient outcomes.
CONDITIONS
Brief Title
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- Informed consent for PLCRC including additional blood withdrawals, tissue collection for research, and future experimental research invitations
- Inclusion in observational PLCRC-MEDOCC substudy
- Histologically confirmed stage II colon cancer
- Fit enough to receive combination chemotherapy (fluoropyrimidine and oxaliplatin) as judged by treating physician
You will not qualify if you...
- Indication for adjuvant chemotherapy according to treating physician
- Another malignancy in previous 5 years except treated carcinoma in situ or non-melanoma skin cancer
- Incomplete primary tumor resection (R1 or R2 resection)
- Contraindication for fluoropyrimidines or oxaliplatin
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 8 to 12 weeks after surgery
Participants have blood samples analyzed for circulating tumor DNA (ctDNA) after surgery to determine treatment strategy.
1 visit (in-person)
Duration - 3 months
Participants with detectable ctDNA receive adjuvant chemotherapy for 3 months (4 cycles of CAPOX) according to routine clinical practice. Participants without detectable ctDNA receive routine follow-up at the surgical department.
4 chemotherapy cycles and regular visits for treatment and monitoring
Duration - Up to 10 years
Participants are monitored for recurrence, survival, quality of life, and cost-effectiveness outcomes over several years.
Follow-up visits at 2, 5, and 10 years after surgery
Trial Site Locations
Total: 29 locations
1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Actively Recruiting
2
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Actively Recruiting
3
Ziekenhuisgroep Twente
Almelo, Netherlands
Actively Recruiting
4
Flevoziekenhuis
Almere Stad, Netherlands
Actively Recruiting
5
Meander Medisch Centrum
Amersfoort, Netherlands
Actively Recruiting
6
NKI-AVL
Amsterdam, Netherlands
Actively Recruiting
7
Rijnstate
Arnhem, Netherlands
Actively Recruiting
8
Amphia Ziekenhuis
Breda, Netherlands
Actively Recruiting
9
Reinier de Graaf Gasthuis
Delft, Netherlands
Actively Recruiting
10
Deventer Ziekenhuis
Deventer, Netherlands
Actively Recruiting
11
Albert Schweizer Ziekenhuis
Dordrecht, Netherlands
Actively Recruiting
12
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Actively Recruiting
13
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Actively Recruiting
14
Rivas
Gorinchem, Netherlands
Actively Recruiting
15
Spaarne Gasthuis
Haarlem, Netherlands
Actively Recruiting
16
Ziekenhuis St. Jansdal
Harderwijk, Netherlands
Actively Recruiting
17
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
18
Van Weel-Bethesda Ziekenhuis
Middelharnis, Netherlands
Actively Recruiting
19
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Actively Recruiting
20
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Actively Recruiting
21
Bravis Ziekenhuis
Roosendaal, Netherlands
Actively Recruiting
22
Ikazia Ziekenhuis
Rotterdam, Netherlands
Actively Recruiting
23
Haaglanden MC
The Hague, Netherlands
Actively Recruiting
24
Bernhoven
Uden, Netherlands
Actively Recruiting
25
Diakonessenhuis
Utrecht, Netherlands
Actively Recruiting
26
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
27
Maxima Medisch Centrum
Veldhoven, Netherlands
Actively Recruiting
28
VieCuri Medisch Centrum
Venlo, Netherlands
Actively Recruiting
29
St. Jans Gasthuis
Weert, Netherlands
Actively Recruiting
Research Team
M
Miriam Koopman, Prof. dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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