Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
NCT ID: NCT06434896
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1320 participants
INTERVENTIONAL
2020-03-05
2035-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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ctDNA-based treatment group
Patients 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.
ctDNA analysis after surgery
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
Standard of care group
The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.
No interventions assigned to this group
Interventions
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ctDNA analysis after surgery
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Personal Genome Diagnostics
INDUSTRY
The Netherlands Cancer Institute
OTHER
UMC Utrecht
OTHER
Responsible Party
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Miriam Koopman
Prof. dr.
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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J.F.M. Pruijt
Role: primary
M.P. Hendriks
Role: primary
R. Hoekstra
Role: primary
J.D.W. van der Bilt
Role: primary
J.M. van Dodewaard
Role: primary
K. Bolhuis
Role: primary
I. Werter
Role: primary
M. Streppel
Role: primary
A.J. Verschoor
Role: primary
L.W. Kessels
Role: primary
M. Vidakovic
Role: primary
M. Verstappen
Role: primary
H.K. van Halteren
Role: primary
M.A. Davidis
Role: primary
H.B.A.C. Stockmann
Role: primary
A.P. Schouten van der Velden
Role: primary
L.B.J. Valkenburg
Role: primary
A.I. de Vos
Role: primary
M. Los
Role: primary
J. Janssen
Role: primary
S. Boudewijns
Role: primary
F.E. de Jongh
Role: primary
F.J.F. Jeurissen
Role: primary
J. van Extel
Role: primary
L. van Leeuwen
Role: primary
Miriam Koopman
Role: primary
L.H.J Simkens
Role: primary
J. Konsten
Role: primary
N.A.J.B. Peters
Role: primary
Other Identifiers
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NL71881.041.19
Identifier Type: -
Identifier Source: org_study_id
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