ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
About this trial
This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,
Is ≥ 18 years of age,
Has histologically confirmed colorectal adenocarcinoma,
Has resected primary tumor or is eligible to primary tumor and CRLM (in case of synchronous metastases) resection within 6 months prior to study inclusion,
Disqualifiers
Has definitively unresectable CLRM,
Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,
Has not resected primary rectal tumor (low and middle),
Has history of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix,
Trial population
Active file in oncology department
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Disease-free survival (DFS) in patients who undergo curative-intent resection of colorectal liver metastasis (CRLM)
DFS is defined as the time from complete surgical resection (following first surgery if one-stage surgery or second surgery if two-stage strategy) to first documented event (relapse or death, whichever occurred first), or until last contact if no event occurs.
Time frame
Up to 36 monthsSecondary outcomes
1
Number of event-free survival (EFS) in patients who undergo curative-intent resection of CRLM.
EFS is defined as time between inclusion until the occurrence of an event: disease progression, relapse, disease progression, or death from any reason.
Time frame
Up to 4 years2
Overall survival (OS) n patients who undergo curative-intent resection of CRLM.
OS is defined as the time between inclusion and death. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
Time frame
Up to 4 years3
Time to surgical failure (TSF) in patients who undergo curative-intent resection of CRLM.
TFS is defined as the time from initial surgery until the first unresectable recurrence or death from any cause or the date of the last follow-up, at which point data are censored.
Time frame
Up to 4 years4
Prognostic value of ctDNA
Prognostic value of ctDNA: * post-operative ctDNA detection, * relative change in ctDNA level after curative resection of CRLM, * ctDNA in different subgroups of patients classified according to the type of surgical strategy (standard approach, combined surgery, reverse strategy, two-staged hepatectomy),
Time frame
Up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov