A prospective randomized phase II trial of FOLFIRINOX alone versus FOLFIRINOX followed by radiochemotherapy in patients with locally advanced, primarily inoperable pancreatic cancer

ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 sites112 target enrollmentJuly 18, 2012

Overview

No summary available.

Registry

who.int

Start Date

July 18, 2012

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ABCSG (Austrian Breast & Colorectal Cancer Study Group)

•Informed consent signed prior to randomization and prior to any study specific procedure
•Patients with histologically proven PDAC, classified as locally advanced, primarily inoperable disease;
•patients with suspicious peripancreatic lymph nodes at initial staging, accessible by surgery are included in the study
•Tumor must have at least one diameter of 15 mm assessed with conventional imaging techniques (e.g. CT, MRI) and at least on diameter of 10 mm measured by contrast enhanced CT
•Patients scheduled for neoadjuvant treatment by the interdisciplinary tumor board
•Radiologically determinable disease defined by RECIST version 1\.1 within 4 weeks prior to randomization
•ECOG performance status \=1 or Karnofsky \=70%
•Adequate hematologic function, as follows (\= 7d prior to randomization):
•o absolute neutrophil count (ANC) \=1\.5 x 109/L (in case ANC is not routinely measured, as alternatively relative neutrophil count \> 50% is acceptable)
•o white blood cell count (WBC) \= 3\.0 x 109/L

•External biliary drain (Common bile duct stenting allowed)
•Major surgery within 4 weeks prior to start of study treatment
•Any past or current history of other malignancies (except in situ carcinoma, non\-metastatic non\-melanomatous skin cancers) less than 2 years prior to randomization
•Any radiological suspicion, or histological proof of distant metastases or extra\-pancreatic disease other than regional lymph node enlargement at initial staging
•Any chemo\- or radiotherapy for PDAC prior to study inclusion
•Concurrent or prior systemic antitumor therapy within the last 2 years
•Active infection requiring systemic treatment or any uncontrolled infections \< 14 days prior to randomization
•Concurrent administration of other IMP during treatment phase
•Concurrent participation in another clinical trial with the same primary endpoint
•Pregnancy, lactation, women of childbearing potential not willing to use effective means of contraception until 6 months after completion of study treatment