Gastric or gastroesophageal cancer
Conditions
Brief summary
The rate of patients with ctDNA clearance after adjuvant T-DXd plus capecitabine/5-fluorouracil versus post-operative FLOT continuation treatment at 1 year from randomization in the intention-to-treat population. Patients with disease relapse or death before the 12-month post-randomization timepoint will be considered in the intention-to-treat population as not having achieved ctDNA clearance.
Detailed description
Disease-free survival, defined as time from the randomization in the study to the occurrence of disease relapse (local and/or distant), second GC/GEJC primary, or death from any cause, Overall survival, defined as time from the randomization in the study to the occurrence of death, Metastases-free survival, defined as time from the randomization in the study to the first evidence of metastases according to the radiological and clinical assessments detailed in the procedures or death from any cause
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of patients with ctDNA clearance after adjuvant T-DXd plus capecitabine/5-fluorouracil versus post-operative FLOT continuation treatment at 1 year from randomization in the intention-to-treat population. Patients with disease relapse or death before the 12-month post-randomization timepoint will be considered in the intention-to-treat population as not having achieved ctDNA clearance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, defined as time from the randomization in the study to the occurrence of disease relapse (local and/or distant), second GC/GEJC primary, or death from any cause, Overall survival, defined as time from the randomization in the study to the occurrence of death, Metastases-free survival, defined as time from the randomization in the study to the first evidence of metastases according to the radiological and clinical assessments detailed in the procedures or death from any cause | — |
Countries
Italy