Neoadjuvant Plus Adjuvant or Only Adjuvant Nab- Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

April 30, 2021

Study Completion Date

October 31, 2022

Conditions
Resectable Pancreatic CancerDuctal Adenocarcinoma of the Pancreas
Interventions
DRUG

perioperative nab-paclitaxel/gemcitabine

2 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles) followed by 3 weeks of rest and subsequent tumor surgery. Starting within 12 weeks after surgery adjuvant chemotherapy with 4 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles)

DRUG

adjuvant nab-paclitaxel/gemcitabine

Tumor surgery followed by adjuvant chemotherapy with 6 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles, starting within 12 weeks after surgery)

Trial Locations (1)

89081

University of Ulm, Dept. of Internal Medicine I, Ulm

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

collaborator

ClinAssess GmbH

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER