Actively Recruiting
Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-04-15
162
Participants Needed
8
Research Sites
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 on the date the consent is signed
- Histologically or cytologically proven metastatic pancreatic adenocarcinoma
- One or more measurable metastatic lesions by scanner or MRI
- Previous treatment for non-metastatic disease allowed if at least 6 months have passed since last treatment
- WHO performance status of 0 or 1
- Uracilemia level less than 16 ng/ml
- Acceptable blood counts: neutrophils 2 x 10^9/L, platelets 100,000/mm3, hemoglobin 9 g/dl
- Acceptable liver and kidney function within 14 days before treatment start
- Calcium, magnesium, and potassium levels within normal limits
- Agreement to use adequate contraception if sexually active during treatment and for 6 months after
- Signed informed consent
- Affiliated with French national social security
You will not qualify if you...
- Known brain metastasis
- Previous treatment for metastatic disease including radiotherapy, surgery, chemotherapy, or experimental therapy
- Major surgery other than diagnostic surgery within 4 weeks before study treatment
- Known Gilbert's syndrome or homozygous for UGT1A1 * 28
- Other cancers or history of cancer except certain treated types without chemotherapy and no signs of disease for 3 years
- High cardiovascular risk including recent coronary stent or heart attack within 6 months
- Peripheral sensory neuropathy grade 2 or higher
- ECG showing prolonged QTc interval (>450 ms men, >470 ms women)
- Serious diseases interfering with study participation or safety
- Allergy or intolerance to study drugs or excipients
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test
- Use of vitamin K antagonists
- Treatment with brivudine within 4 weeks before or after 5-fluorouracil
- Active uncontrolled infections requiring systemic treatment
- Active HIV, hepatitis B or C infection
- History of peripheral arterial disease, inflammatory bowel disease, pulmonary fibrosis, or interstitial pneumonia
- Live attenuated vaccine within 10 days before inclusion and up to 6 months post-treatment
- Refusal or inability to comply with study procedures
- Inability to follow-up due to geographic, social, or psychological reasons
- Participation in another investigational clinical trial within 30 days
- Legal incapacity or guardianship
AI-Screening
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Trial Site Locations
Total: 8 locations
1
CHU Grenoble
Grenoble, Auvergne-Rhône-Alpes, France, 38000
Not Yet Recruiting
2
CHU St Etienne
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42000
Active, Not Recruiting
3
Institut GODINOT
Reims, Grand Est, France, 51100
Actively Recruiting
4
CHU St Eloi
Montpellier, Herault, France, 34295
Actively Recruiting
5
Institut régional du Cancer de Montpellier
Montpellier, Hérault, France, 34298
Actively Recruiting
6
Centre Catalan d'Oncologie
Perpignan, Pyrénées-Orientales, France, 66000
Not Yet Recruiting
7
CH de Perpignan
Perpignan, Pyrénées-Orientales, France, 66046
Actively Recruiting
8
Centre Georges-François Leclerc
Dijon, France, 21079
Actively Recruiting
Research Team
A
Aurore MOUSSION, MD
CONTACT
F
Fabienne PORTALES, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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