resected pancreatic adenocarcinoma
Conditions
Brief summary
Phase 2: The primary efficacy endpoint is the Disease Free Survival (DFS), defined as the time from randomization to locoregional recurrence, occurrence of distant metastases or second pancreatic cancer, or death (all causes) whichever occurred first. Patients free of events will be censored at the date of the last disease evaluation either during study treatment period or during follow-up period (1,53)., Phase 3: The primary efficacy endpoint is the Overall Survival (OS), defined as the time from randomization to the death from any cause. Alive patient will be censored at last date known to be alive either during study treatment period or during follow-up period
Detailed description
• Incidence and grade for Adverse events (AEs), drug related AEs, drug related AE leading to dose reduction or discontinuation during treatment, SAE and SUSAR, according to NCI-CTCAE V5.0., • OS (phase 2), • DFS (Phase 3), • Time to metastatic recurrence defined as the time from randomization to occurrence of distant metastases. Patients with locoregional recurrence, second pancreatic cancer, or death (all causes) without metastatic recurrence will be censored at time of event whichever occurred first. Patients free of locoregional recurrence, second pancreatic cancer, or death (all causes) without metastatic recurrence will be censored at the date of the last disease evaluation, • Early recurrence < 6 months after surgical randomization, • Health related quality of life EORTC QLQ-C30 and QLQ-PAN26 questionnaires, • Tumour response and clinico-pathological criteria (size (T stage); margins (R0/R1 status); lymph node invasion (N stage)), DFS and OS
Interventions
DRUGsolution injectable
DRUGsolution à diluer pour perfusion
DRUGIrinotecan Accord 20 mg/ml Solution à diluer pour perfusion
Sponsors
Centre Hospitalier Universitaire Rouen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: The primary efficacy endpoint is the Disease Free Survival (DFS), defined as the time from randomization to locoregional recurrence, occurrence of distant metastases or second pancreatic cancer, or death (all causes) whichever occurred first. Patients free of events will be censored at the date of the last disease evaluation either during study treatment period or during follow-up period (1,53)., Phase 3: The primary efficacy endpoint is the Overall Survival (OS), defined as the time from randomization to the death from any cause. Alive patient will be censored at last date known to be alive either during study treatment period or during follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence and grade for Adverse events (AEs), drug related AEs, drug related AE leading to dose reduction or discontinuation during treatment, SAE and SUSAR, according to NCI-CTCAE V5.0., • OS (phase 2), • DFS (Phase 3), • Time to metastatic recurrence defined as the time from randomization to occurrence of distant metastases. Patients with locoregional recurrence, second pancreatic cancer, or death (all causes) without metastatic recurrence will be censored at time of event whichever occurred first. Patients free of locoregional recurrence, second pancreatic cancer, or death (all causes) without metastatic recurrence will be censored at the date of the last disease evaluation, • Early recurrence < 6 months after surgical randomization, • Health related quality of life EORTC QLQ-C30 and QLQ-PAN26 questionnaires, • Tumour response and clinico-pathological criteria (size (T stage); margins (R0/R1 status); lymph node invasion (N stage)), DFS and OS | — |
Countries
France
Outcome results
None listed