locally advanced or metastatic Pancreatic ductal adenocarcinoma
Conditions
Brief summary
Evaluable patients for OS rate at 12 months will be patients alive at 12 months and patients dead within 12 months; patients lost to follow-up before 12 months without confirmation of death will be non-evaluable. The OS is defined according to the DATECAN consensus as the time from randomization to death for any reason. In the absence of confirmation of death, survival time will be censored at the date of the last clinical assessment.
Detailed description
PFS by centralized review of CT-scan imaging., All grade and severe (grade 3-5) toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Response according to RECIST v1.1 77 (centralized review of CT-scan imaging), HRQoL assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire, Q-TWiST, Potential predictive biomarkers (blood and tumor tissue), Immune-related AEs (imAEs) according to sarcopenia
Interventions
Sponsors
Association Gercor
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluable patients for OS rate at 12 months will be patients alive at 12 months and patients dead within 12 months; patients lost to follow-up before 12 months without confirmation of death will be non-evaluable. The OS is defined according to the DATECAN consensus as the time from randomization to death for any reason. In the absence of confirmation of death, survival time will be censored at the date of the last clinical assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS by centralized review of CT-scan imaging., All grade and severe (grade 3-5) toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Response according to RECIST v1.1 77 (centralized review of CT-scan imaging), HRQoL assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire, Q-TWiST, Potential predictive biomarkers (blood and tumor tissue), Immune-related AEs (imAEs) according to sarcopenia | — |
Countries
France
Outcome results
None listed