Trial Title:
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
NCT ID:
NCT06434896
Condition:
Circulating Tumor DNA
Recurrence
Colon Cancer Stage II
Conditions: Official terms:
Colonic Neoplasms
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
ctDNA analysis after surgery
Description:
ctDNA analysis of post-surgery blood samples will be performed directly after informed
consent for MEDOCC-CrEATE.
Arm group label:
ctDNA-based treatment group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jeroen Bosch Ziekenhuis
Address:
City:
's Hertogenbosch
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J.F.M. Pruijt
Facility:
Name:
Noordwest Ziekenhuisgroep
Address:
City:
Alkmaar
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M.P. Hendriks
Facility:
Name:
Ziekenhuisgroep Twente
Address:
City:
Almelo
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
R. Hoekstra
Facility:
Name:
Flevoziekenhuis
Address:
City:
Almere
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J.D.W. van der Bilt
Facility:
Name:
Meander Medisch Centrum
Address:
City:
Amersfoort
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J.M. van Dodewaard
Facility:
Name:
Rijnstate
Address:
City:
Arnhem
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
I. Werter
Facility:
Name:
Amphia Ziekenhuis
Address:
City:
Breda
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M. Streppel
Facility:
Name:
Reinier de Graaf Gasthuis
Address:
City:
Delft
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A.J. Verschoor
Facility:
Name:
Haaglanden MC
Address:
City:
Den Haag
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
F.J.F. Jeurissen
Facility:
Name:
Deventer Ziekenhuis
Address:
City:
Deventer
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
L.W. Kessels
Facility:
Name:
Albert Schweizer Ziekenhuis
Address:
City:
Dordrecht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M. Vidakovic
Facility:
Name:
Ziekenhuis Gelderse Vallei
Address:
City:
Ede
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M. Verstappen
Facility:
Name:
Admiraal de Ruyter Ziekenhuis
Address:
City:
Goes
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
H.K. van Halteren
Facility:
Name:
Rivas
Address:
City:
Gorinchem
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M.A. Davidis
Facility:
Name:
Spaarne Gasthuis
Address:
City:
Haarlem
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
H.B.A.C. Stockmann
Facility:
Name:
Ziekenhuis St. Jansdal
Address:
City:
Harderwijk
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A.P. Schouten van der Velden
Facility:
Name:
Maastricht UMC
Address:
City:
Maastricht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
L.B.J. Valkenburg
Facility:
Name:
Van Weel-Bethesda Ziekenhuis
Address:
City:
Middelharnis
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A.I. de Vos
Facility:
Name:
St. Antonius Ziekenhuis
Address:
City:
Nieuwegein
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M. Los
Facility:
Name:
Canisius Wilhelmina Ziekenhuis
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J. Janssen
Facility:
Name:
Bravis Ziekenhuis
Address:
City:
Roosendaal
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
S. Boudewijns
Facility:
Name:
Ikazia Ziekenhuis
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
F.E. de Jongh
Facility:
Name:
Bernhoven
Address:
City:
Uden
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J. van Extel
Facility:
Name:
Diakonessenhuis
Address:
City:
Utrecht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
L. van Leeuwen
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Miriam Koopman
Facility:
Name:
Maxima Medisch Centrum
Address:
City:
Veldhoven
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
L.H.J Simkens
Facility:
Name:
VieCuri Medisch Centrum
Address:
City:
Venlo
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
St. Jans Gasthuis
Address:
City:
Weert
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
N.A.J.B. Peters
Start date:
March 5, 2020
Completion date:
March 2035
Lead sponsor:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
Personal Genome Diagnostics (PGDx)
Agency class:
Other
Collaborator:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
UMC Utrecht
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434896
