Ampullary adenocarcinoma
Conditions
Brief summary
The primary endpoint is the 2 years Disease-free survival rate. DFS will be calculated from date of randomization to the date of first relapse (locally and/or metastatic) or date of death (all causes). Patients alive without relapse will be censored at the date of last news. Second cancer will not be considered as an event. The relapse will be assessed by the investigator according to RECIST v1.1 criteria.
Detailed description
OS is defined as the time between randomization and death (all causes). Patients alive will be censored at the date of last news., Rate of patients completing 3 and 6-month chemotherapy schedule according to percentage of administered dose of each product. Percentage of administrated dose will be calculated as the ratio of dose received over dose planned for each product. A completed cycle will be defined by at least 80% of each product dispensed, All grade and grade 3-4, will be described using NCI-CTCAE (National Cancer Institute – Common Terminology Criteria for Adverse Events) version 5.0, Quality of life will be assessed according to the questionnaire of EORTC QLQ-C30 and PAN26 questionnaires.
Interventions
DRUGGEMCITABINE HYDROCHLORIDE
DRUGFLUOROURACIL
DRUGOXALIPLATIN
DRUGIRINOTECAN
DRUGCALCIUM FOLINATE
Sponsors
Centre Hospitalier Universitaire De Dijon
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the 2 years Disease-free survival rate. DFS will be calculated from date of randomization to the date of first relapse (locally and/or metastatic) or date of death (all causes). Patients alive without relapse will be censored at the date of last news. Second cancer will not be considered as an event. The relapse will be assessed by the investigator according to RECIST v1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS is defined as the time between randomization and death (all causes). Patients alive will be censored at the date of last news., Rate of patients completing 3 and 6-month chemotherapy schedule according to percentage of administered dose of each product. Percentage of administrated dose will be calculated as the ratio of dose received over dose planned for each product. A completed cycle will be defined by at least 80% of each product dispensed, All grade and grade 3-4, will be described using NCI-CTCAE (National Cancer Institute – Common Terminology Criteria for Adverse Events) version 5.0, Quality of life will be assessed according to the questionnaire of EORTC QLQ-C30 and PAN26 questionnaires. | — |
Countries
France
Outcome results
None listed