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Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

NCT04570943 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-12-05

No results posted yet for this study

Summary

The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.

The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.

Conditions

  • Locally Advanced Pancreatic Adenocarcinoma

Interventions

COMBINATION_PRODUCT

Gabrinox

Regimen: GEMBRAX Other Names: Albumin bound paclitaxel 125 mg/m² + Gemcitabine 1000 mg/m² Regimen: FOLFIRINOX Other Names: Oxaliplatin 85 mg/m² + Leucovorin 200 mg/m² + Irinotecan 180 mg/m² + 5FU bolus 400mg/m² + 5FU continuous 2400 mg/m² Gembrax + Folfirinox = GABRINOX

RADIATION

MRI-GUIDED STEREOTACTIC RADIOTHERAPY

Radiotherapy will start between 5 and 6 weeks after the last injection of chemotherapy (FOLFIRINOX regimen) in non-progressive patients after Gabrinox. Stereotactic adaptive radiotherapy in five fractions: prescription dose in five fractions of 10 Gy/day on consecutive days. At least two sessions/week should be performed. An interval of at least 18 hours between fractions is recommended.

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Fabienne Portalès, MD · Institut de Cancérologie de Montpellier (ICM)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2028-01-31
Completion
2030-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570943 on ClinicalTrials.gov