At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically proven metastatic pancreatic adenocarcinoma
- ✓One or more metastatic lesions measurable by imaging (RECIST 1.1)
- ✓Previous treatment for non-metastatic disease allowed if ≥6 months since last treatment
- ✓Age 18-75 years
- ✕Known brain metastasis
- ✕Prior treatment with radiotherapy, surgery, chemotherapy or experimental therapy for metastatic disease
- ✕Major surgery within 4 weeks of day 1 of study treatment
- ✕Known Gilbert's syndrome or homozygous UGT1A1 *28
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Trial Evaluating the Efficacy of a Sequential Treatment Gemcitabine Plus Nab-paclitaxel (Gembrax) Followed by Folfirinox Versus Folfirinox Alone in Patients Treated in First Metastatic Line Pancreatic Cancer
In Brief
A Phase 2 clinical trial evaluating GEMBRAX/FOLFIRINOX Arm A and FOLFIRINOX Arm B for Metastatic Pancreatic Cancer. Currently recruiting, targeting 162 participants across 8 sites.
Detailed 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
Study Details
Timeline
Interventions
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
Patients in this arm received : A maximum of 3 cycles (6 months) of chemotherapy. One cycle = 4 administrations of FOLFIRINOX