The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks
25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
overall survival
Time frame: 9 months
clinical benefit response
Time frame: baseline and at end of every cycle of therapy
quality of life
Time frame: baseline and at end of every cycle of therapy
objective response
Time frame: after 7 weeks of therapy
time to progression
Time frame: 6 months
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Ospedal Miulli
Acquaviva delle Fonti, Italy
Ospedale Regionale Torrette
Ancona, Italy
Presidio Osp. Alto Garda e Ledro
Arco, Italy
Centro Riferimento Oncologico
Aviano, Italy
Istituto Oncologico Giovanni Paolo II
Bari, Italy
Azienda Ospedaliera G. Rummo
Benevento, Italy
Ospedale Fatebenefratelli
Benevento, Italy
Ospedale Riuniti
Bergamo, Italy
Ospedale degli Infermi
Biella, Italy
Ospedale Regionale
Bolzano, Italy
...and 35 more locations