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

PHASE2RecruitingINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

June 16, 2021

Primary Completion Date

January 31, 2028

Study Completion Date

June 30, 2030

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 of five fractions of 10 Gy/each on the planning target volume (PTV). At least two sessions/week should be performed. An interval of at least 18 hours between fractions is recommended."

Trial Locations (9)

13009

RECRUITING

Institut Paoli Calmettes, Marseille

21079

RECRUITING

Centre Georges-François Leclerc, Dijon

30029

RECRUITING

CHU Carémeau, Nîmes

34295

RECRUITING

CHU Saint-Eloi, Montpellier

34298

RECRUITING

Institut régional du Cancer de Montpellier, Montpellier

35042

NOT_YET_RECRUITING

Centre Eugène Marquis, Rennes

75013

RECRUITING

Hôpital Pitié Salpétriêre, Paris

Unknown

NOT_YET_RECRUITING

Hôpital Beaujon, Clichy

NOT_YET_RECRUITING

Hopital Paul Brousse, Villejuif

All Listed Sponsors
lead

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER