Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
CrEATE
1 other identifier
interventional
1,320
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2020
CompletedFirst Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2035
April 10, 2025
April 1, 2025
15 years
April 29, 2024
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
8-12 weeks after surgery
Secondary Outcomes (6)
Recurrence Rate
2 and 5 years after surgery
Disease Free Survival rate
2 and 5 years after surgery
Disease-related Overall Survival rate
5 years after surgery
Time to Recurrence
From date of randomization until the date of recurrence, assessed up to 5 years.
Quality of Life after treatment
10 years
- +1 more secondary outcomes
Study Arms (2)
ctDNA-based treatment group
EXPERIMENTALPatients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.
Standard of care group
NO INTERVENTIONThe treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.
Interventions
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
Eligibility Criteria
You may qualify if:
- 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
- Histological confirmed stage II colon cancer
- Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Personal Genome Diagnosticscollaborator
- The Netherlands Cancer Institutecollaborator
Study Sites (29)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
NKI-AVL
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Albert Schweizer Ziekenhuis
Dordrecht, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Rivas
Gorinchem, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, Netherlands
Maastricht UMC
Maastricht, Netherlands
Van Weel-Bethesda Ziekenhuis
Middelharnis, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Bravis Ziekenhuis
Roosendaal, Netherlands
Ikazia Ziekenhuis
Rotterdam, Netherlands
Haaglanden MC
The Hague, Netherlands
Bernhoven
Uden, Netherlands
Diakonessenhuis
Utrecht, Netherlands
UMC Utrecht
Utrecht, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
St. Jans Gasthuis
Weert, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr.
Study Record Dates
First Submitted
April 29, 2024
First Posted
May 30, 2024
Study Start
March 5, 2020
Primary Completion (Estimated)
March 1, 2035
Study Completion (Estimated)
March 1, 2035
Last Updated
April 10, 2025
Record last verified: 2025-04