Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients
NCT05065801 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2026-04-15
Summary
The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer
Conditions
Interventions
- COMBINATION_PRODUCT
-
GEMBRAX/FOLFIRINOX Arm A
Patients in the experimental arm received sequential treatment: A maximum of 6 cycles (12 months) of chemotherapy; One cycle = 3 administrations of GEMBRAX followed by 2 administrations of FOLFIRINOX
- COMBINATION_PRODUCT
-
FOLFIRINOX Arm B
Patients in this arm received : A maximum of 3 cycles (6 months) of chemotherapy. One cycle = 4 administrations of FOLFIRINOX
Sponsors & Collaborators
-
Institut du Cancer de Montpellier - Val d'Aurelle
lead OTHER
Principal Investigators
-
Fabienne PORTALES, MD · Institut de Cancérologie de Montpellier (ICM)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-11
- Primary Completion
- 2026-12-30
- Completion
- 2028-06-30
Countries
- France
Study Locations
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