Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer
- Registration Number
- NCT00813696
- Lead Sponsor
- Istituti Tumori Giovanni Paolo II
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- Histologic or cytologic diagnosis pancreatic cancer
- inoperable stage II or stage III or IV disease(UICC, 1997)
- Age 18 to 75 years
- Karnofsky Performance status > 50
- Signed informed consent
- Previous chemotherapy
- Cerebral metastases
- Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
- Leukocytes < 4000 or neutrophils < 2000 or platelets < 100000 or hemoglobin < 10 g/dl
- Creatinine value > upper normal limit
- GOT or GPT > 2.5 times upper normal limit or bilirubin > 1.5 times upper normal limit in absence of hepatic metastases
- Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
- Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
- Inability to provide informed consent
- Inability to comply with follow-up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A gemcitabine cisplatin + gemcitabine A cisplatin cisplatin + gemcitabine B gemcitabine gemcitabine
- Primary Outcome Measures
Name Time Method overall survival 9 months
- Secondary Outcome Measures
Name Time Method clinical benefit response baseline and at end of every cycle of therapy quality of life baseline and at end of every cycle of therapy objective response after 7 weeks of therapy time to progression 6 months
Trial Locations
- Locations (42)
Centro Catanese di Oncologia
🇮🇹Catania, Italy
Ospedale Cardarelli
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria
🇮🇹Ferrara, Italy
Ospedal Miulli
🇮🇹Acquaviva delle Fonti, Italy
Istituto Oncologico Giovanni Paolo II
🇮🇹Bari, Italy
Ospedale Riuniti
🇮🇹Bergamo, Italy
Ospedale degli Infermi
🇮🇹Biella, Italy
Università di Chieti "D'Annunzio"
🇮🇹Chieti, Italy
Ospedale Valduce
🇮🇹Como, Italy
Azienda Ospedaliera Vito Fazzi
🇮🇹Lecce, Italy
Ospedale San Carlo
🇮🇹Potenza, Italy
Policlinico Militare Celio
🇮🇹Roma, Italy
Ospedale Regionale Torrette
🇮🇹Ancona, Italy
Centro Riferimento Oncologico
🇮🇹Aviano, Italy
Policlinico Universitario
🇮🇹Cagliari, Italy
Ospedale Umberto I
🇮🇹Lugo, Italy
Pres. Osp. di Manerbio
🇮🇹Manerbio, Italy
Ospedale L. Sacco
🇮🇹Milano, Italy
Ospedale San Paolo
🇮🇹Milano, Italy
Ospedale G. Moscati
🇮🇹Monteforte Irpino, Italy
Ospedale San Gerardo
🇮🇹Monza, Italy
Istituto Nazionale Tumori
🇮🇹Napoli, Italy
Casa di Cura La Maddalena
🇮🇹Palermo, Italy
Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
Azienda Policlinico S. Andrea
🇮🇹Roma, Italy
Ospedale San Raffaele
🇮🇹Roma, Italy
Polo Oncologico Istituto Regina Elena
🇮🇹Roma, Italy
Centro Oncologico
🇮🇹S. Vito al Tagliamento, Italy
Ospedale Santa Chiara
🇮🇹Trento, Italy
Ospedale Fatebenefratelli
🇮🇹Roma, Italy
Azienda Ospedaliera G. Rummo
🇮🇹Benevento, Italy
Presidio Osp. Alto Garda e Ledro
🇮🇹ARco, Italy
Ospedale Regionale
🇮🇹Bolzano, Italy
Ospedale A. Cardarelli
🇮🇹Campobasso, Italy
Ospedale Ramazzini
🇮🇹Carpi, Italy
Azienda Ospedale Careggi
🇮🇹Firenze, Italy
Ospedale Santa Croce
🇮🇹Fano, Italy
Ospedale Civile
🇮🇹Rovigo, Italy
Policlinico Giaccone
🇮🇹Palermo, Italy
Ospedale San Salvatore-Muraglia
🇮🇹Pesaro, Italy
Azienda Ospedaliera Treviglio-Caravaggio
🇮🇹Treviglio, Italy
Ospedale San Bortolo
🇮🇹Vicenza, Italy