RecruitingPhase 2NCT05065801

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

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


Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

162 participants

Start Date

Jan 11, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether starting with Gembrax (gemcitabine + nab-paclitaxel) for two months, then switching to FOLFIRINOX chemotherapy, works better than FOLFIRINOX alone as first-line treatment for metastatic pancreatic cancer. The idea is that an initial different regimen may help sensitize the cancer to the second regimen. **You may be eligible if...** - You are aged 18–75 with confirmed metastatic pancreatic adenocarcinoma - You have not yet received chemotherapy for metastatic disease (prior treatment for non-metastatic disease is allowed if it was at least 6 months ago) - You are in good health (WHO performance status 0 or 1) with adequate blood and organ function **You may NOT be eligible if...** - You have previously received chemotherapy for metastatic pancreatic cancer - You have severe heart, liver, or kidney problems that make chemotherapy unsafe - You have a uracilemia level above 16 ng/mL (a marker that indicates risk of serious 5-FU toxicity) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTGEMBRAX/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_PRODUCTFOLFIRINOX Arm B

Patients in this arm received : A maximum of 3 cycles (6 months) of chemotherapy. One cycle = 4 administrations of FOLFIRINOX


Locations(8)

CHU Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

CHU St Etienne

Saint-Etienne, Auvergne-Rhône-Alpes, France

Institut GODINOT

Reims, Grand Est, France

CHU St Eloi

Montpellier, Herault, France

Institut régional du Cancer de Montpellier

Montpellier, Hérault, France

Centre Catalan d'Oncologie

Perpignan, Pyrénées-Orientales, France

CH de Perpignan

Perpignan, Pyrénées-Orientales, France

Centre Georges-François Leclerc

Dijon, France

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NCT05065801


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