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Trials / Recruiting

RecruitingNCT06434896

Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
1,320 (estimated)
Sponsor
UMC Utrecht · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERctDNA analysis after surgeryctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.

Timeline

Start date
2020-03-05
Primary completion
2035-03-01
Completion
2035-03-01
First posted
2024-05-30
Last updated
2025-04-10

Locations

29 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06434896. Inclusion in this directory is not an endorsement.