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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,320
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
RECRUITINGNoordwest Ziekenhuisgroep
Alkmaar, Netherlands
RECRUITINGZiekenhuisgroep Twente
Almelo, Netherlands
RECRUITINGFlevoziekenhuis
Almere Stad, Netherlands
RECRUITINGMeander Medisch Centrum
Amersfoort, Netherlands
RECRUITINGNKI-AVL
Amsterdam, Netherlands
RECRUITINGRijnstate
Arnhem, Netherlands
RECRUITINGAmphia Ziekenhuis
Breda, Netherlands
RECRUITINGReinier de Graaf Gasthuis
Delft, Netherlands
RECRUITINGDeventer Ziekenhuis
Deventer, Netherlands
RECRUITING...and 19 more locations
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
Time frame: 8-12 weeks after surgery
Recurrence Rate
Proportion of patients that will experience disease recurrence
Time frame: 2 and 5 years after surgery
Disease Free Survival rate
Proportion of patients that are alive and free of disease
Time frame: 2 and 5 years after surgery
Disease-related Overall Survival rate
Proportion of patients that are alive
Time frame: 5 years after surgery
Time to Recurrence
Time frame: From date of randomization until the date of recurrence, assessed up to 5 years.
Quality of Life after treatment
Quality of Life (QoL) will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC. Comparison of QoL of the ctDNA positive patients in both study arms will be done using repeated measurements methods, including ACT as factor. QoL will also be analysed for the whole population in both arms of the study. Treatment differences at each QoL assessment time point will be compared by means of the Wilcoxon Rank Sum Test.
Time frame: 10 years
Cost-effectiveness of the ctDNA-based treatment
The cost-effectiveness analysis will be carried out from a societal perspective, including both direct health care costs as well as indirect costs from productivity loss. The health outcome measure in the cost-effectiveness analysis will be the total quality adjusted life years (QALY) per group.
Time frame: 5 years after diagnosis
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