Status:
UNKNOWN
Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer
Lead Sponsor:
Istituti Tumori Giovanni Paolo II
Collaborating Sponsors:
Gruppo Oncologico Italia Meridionale
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00813696
Start Date
April 1 2002
End Date
September 1 2009
Last Update
December 23 2008
Active Locations (45)
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1
Ospedal Miulli
Acquaviva delle Fonti, Italy
2
Ospedale Regionale Torrette
Ancona, Italy
3
Presidio Osp. Alto Garda e Ledro
Arco, Italy
4
Centro Riferimento Oncologico
Aviano, Italy