Stage III colorectal cancer
Conditions
Brief summary
The 3-year Disease-Free Survival (DFS) rate; DFS will be defined as time from randomization to first event (i.e, either a first recurrence local or metastatic (radiological or clinical), second colorectal cancer, or death from any cause). Patients alive without event will be censored at the date of the last follow-up (12). The 3-year DFS rate will be estimated using Kaplan Meier method.
Detailed description
Efficacy endpoints :Disease Free Survival will be defined as time from randomization to first event. Patients alive without event will be censored at the date of the last follow. Overall Survival defined as the time from the date of randomization to the date of documented death from any cause. Patients alive at the end of the study will be censored at the date of the last contact. Time to Recurrence is defined as the time from the date of randomization to the date of first recurrence, Safety endpoints :Safety of treatments (NCI-CTCAE version 6.0) will be determined through the incidence of adverse events (AEs), treatment related adverse events (TRAEs), serious adverse Events (SAE), and death. For ctDNA-negative cohort: Rate of neurotoxicity in each arm in de-escalation cohort (CAPOX vs CAPE), along with comparison between two arms of severity and duration of such neurotoxicity during treatment and at 1 year after treatment., Exploratory endpoints : Quality of life. Identify prognostication of stage III CRC by testing the added value of ctDNA on classical histoprognostic factors. Value of biological factors will be described by absolute or relative variation from baseline. To assess their prognostic or predictive values of DFS/OS, baseline values of these biomarkers will be tested using Cox reg model. For ctDNA-negative: Rate of ctDNA positivation. For ctDNA-positive: Rate of ctDNA negativation, Ancillary studies endpoints: To evaluate several ctDNA detection technics (methylation, sequencing…). To assess the incremental prognostic value contributed by various tumor molecular signatures relative to ctDNA status.
Interventions
DRUGsolution à diluer pour perfusion
Sponsors
Unicancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 3-year Disease-Free Survival (DFS) rate; DFS will be defined as time from randomization to first event (i.e, either a first recurrence local or metastatic (radiological or clinical), second colorectal cancer, or death from any cause). Patients alive without event will be censored at the date of the last follow-up (12). The 3-year DFS rate will be estimated using Kaplan Meier method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints :Disease Free Survival will be defined as time from randomization to first event. Patients alive without event will be censored at the date of the last follow. Overall Survival defined as the time from the date of randomization to the date of documented death from any cause. Patients alive at the end of the study will be censored at the date of the last contact. Time to Recurrence is defined as the time from the date of randomization to the date of first recurrence, Safety endpoints :Safety of treatments (NCI-CTCAE version 6.0) will be determined through the incidence of adverse events (AEs), treatment related adverse events (TRAEs), serious adverse Events (SAE), and death. For ctDNA-negative cohort: Rate of neurotoxicity in each arm in de-escalation cohort (CAPOX vs CAPE), along with comparison between two arms of severity and duration of such neurotoxicity during treatment and at 1 year after treatment., Exploratory endpoints : Quality of life. Identify prognostic | — |
Outcome results
None listed