MedTrace Logo

Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer

NCT02125136 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-12-15

No results posted yet for this study

Summary

The aim ot the study is to investigate the efficacy and safety of two new intensified chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and consecutive conversion of the tumor to resectability.

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.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • ClinAssess GmbH

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Kunzmann Volker, Prof. Dr. · Universitätsklinikum Würzburg/Comprehensive Cancer Center Mainfranken

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2019-03-01
Completion
2020-02-19

Countries

  • Germany

Study Locations

More Related Trials

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 NCT02125136 on ClinicalTrials.gov