Metastatic colorectal cancer
Conditions
Brief summary
Progression-free survival (PFS): defined as the time from the randomization date to disease progression as per RECIST v1.1 or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation available in the study arms treatment setting showing no progression.
Detailed description
Health related Quality of life : - EORTC QLC30 + CR29, EQ-5D-5L questionnaires - 5 prespecified targeted dimensions of interest : Global health/ Pain/ Physical Functioning / Fatigue / Emotional Functioning - Number of days of hospitalization, Toxicities graded according to NCI-CTCAE criteria version, Overall survival (OS): defined as the time from the randomization date to death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period., Disease control rate (DCR): DCR is defined as the proportion of participants with best overall response of confirmed CR or PR or stable disease (SD)., Duration of objective response (DOR): defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR. The actual dates the tumor scans were performed will be used for this calculation. DOR for patients who have not progressed or died at the time of analysis will be censored at the date of last TM, Evaluation of CHUN morphological criteria, Economic evaluation: incremental cost-utility ratio: EuroQol-5D-5L (EQ-5D-5L) questionnaire and VAS (repeated measures at baseline, W8, M4, M6, M8, M10, M12 and end of study M18)
Interventions
Sponsors
Centre Hospitalier Regional Universitaire
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS): defined as the time from the randomization date to disease progression as per RECIST v1.1 or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation available in the study arms treatment setting showing no progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related Quality of life : - EORTC QLC30 + CR29, EQ-5D-5L questionnaires - 5 prespecified targeted dimensions of interest : Global health/ Pain/ Physical Functioning / Fatigue / Emotional Functioning - Number of days of hospitalization, Toxicities graded according to NCI-CTCAE criteria version, Overall survival (OS): defined as the time from the randomization date to death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period., Disease control rate (DCR): DCR is defined as the proportion of participants with best overall response of confirmed CR or PR or stable disease (SD)., Duration of objective response (DOR): defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progres | — |
Countries
France
Outcome results
None listed