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
351 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
P
Personal Genome Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 ≥ 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
You will not qualify if you...
- 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
AI-Screening
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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.
CONTACT
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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