RecruitingPhase 2NCT04570943

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

Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

103 participants

Start Date

Jun 16, 2021

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Pancreatic Adenocarcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment plan for people with locally advanced pancreatic cancer that cannot be removed by surgery. The plan involves two rounds of chemotherapy (GEMBRAX followed by FOLFIRINOX) and then a specialized form of radiation therapy called stereotactic MRI-guided radiotherapy (MR-LINAC). **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with pancreatic cancer (confirmed by biopsy or imaging) - Your cancer has not spread to other organs - Your cancer cannot be surgically removed - Your blood counts, liver, and kidney function are within acceptable ranges - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - Your cancer has spread (metastatic disease) - You have already had treatment for this cancer - You have significant nerve damage or hearing loss that would prevent cisplatin-based chemotherapy - Your cancer marker CA 19-9 is very high (over 500 IU/mL) unless imaging confirms no spread 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_PRODUCTGabrinox

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

RADIATIONMRI-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.