Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
additional blood withdrawals
collection and use of tissue for scientific research
invitation for future (experimental) research within the cohort, including TwiCs studies
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ctDNA analysis after surgery
Other interventionctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
Treatment groups
1,320 Participants
are divided into 2 treatment groupsGroup A: ctDNA-based treatment groupExperimental treatment 1 intervention
Group B: Standard of care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
Time frame
8-12 weeks after surgerySecondary outcomes
1
Recurrence Rate
Proportion of patients that will experience disease recurrence
Time frame
2 and 5 years after surgery2
Disease Free Survival rate
Proportion of patients that are alive and free of disease
Time frame
2 and 5 years after surgery3
Disease-related Overall Survival rate
Proportion of patients that are alive
Time frame
5 years after surgery4
Time to Recurrence
Time frame
From date of randomization until the date of recurrence, assessed up to 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UMC Utrecht
Lead sponsor
Personal Genome Diagnostics
Collaborator
The Netherlands Cancer Institute
Collaborator
Source ClinicalTrials.gov