Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434896
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-29
Brief Title:
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients the MEDOCC-CrEATE Trial
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients the MEDOCC-CrEATE Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CrEATE
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 11 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
Patients included in MEDOCC-CrEATE will be randomized 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None