Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

March 1, 2019

Study Completion Date

February 19, 2020

Conditions
Ductal Adenocarcinoma of the Pancreas
Interventions
DRUG

Gem/nab-Pac

"All patient receive:~2 cycles gemcitabine/nab-paclitaxel (\[Gem/nab-Pac\]; duration of each cycle 28 days)~Then:~Nab-paclitaxel 125 mg/m2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m2 as a 30-minute IV infusion on D1, D8, D15 of each 28-day cycle"

DRUG

FOLFIFINOX

"All patient receive:~2 cycles gemcitabine/nab-paclitaxel (\[Gem/nab-Pac\]; duration of each cycle 28 days)~Then:~Oxaliplatin 85 mg/m2, given as a 2-hour intravenous infusion D1 Folinic acid 400 mg/m2, given as a 2-hour intravenous infusion D1 Irinotecan 180 mg/m2, given as a 90-minutes intravenous infusion D1 (application through a Y-connector parallel to infusion of folinic acid or 30 minutes after start of folinic acid possible) Fluorouracil 400 mg/m2, administered by intravenous bolus, followed by a continuous intravenous infusion of fluorouracil 2400 mg/m2 over a 46-hour period D1.~To be repeated on D1 of each cycle."

Trial Locations (1)

97080

Universitätsklinikum Würzburg/Comprehensive Cancer Center Mainfranken, Würzburg

Sponsors
All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

ClinAssess GmbH

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER