Circulating Tumor DNA, Colon Cancer Stage II, Recurrence
Conditions
Brief 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.
Interventions
OTHERctDNA analysis after surgery
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
Sponsors
UMC Utrecht
Personal Genome Diagnostics
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood. | 8-12 weeks after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 2 and 5 years after surgery | Proportion of patients that will experience disease recurrence |
| Disease Free Survival rate | 2 and 5 years after surgery | Proportion of patients that are alive and free of disease |
| Disease-related Overall Survival rate | 5 years after surgery | Proportion of patients that are alive |
| Time to Recurrence | From date of randomization until the date of recurrence, assessed up to 5 years. | — |
| Quality of Life after treatment | 10 years | 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. |
| Cost-effectiveness of the ctDNA-based treatment | 5 years after diagnosis | 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. |
Countries
Netherlands
Contacts
CONTACTMiriam Koopman, Prof. dr.
Outcome results
None listed