NCT00813696
Unknown
Phase 3
Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Istituti Tumori Giovanni Paolo II42 sites in 1 country400 target enrollmentApril 2002
Overview
- Phase
- Phase 3
- Intervention
- gemcitabine
- Conditions
- Pancreatic Cancer
- Sponsor
- Istituti Tumori Giovanni Paolo II
- Enrollment
- 400
- Locations
- 42
- Primary Endpoint
- overall survival
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
A
cisplatin + gemcitabine
Intervention: gemcitabine
A
cisplatin + gemcitabine
Intervention: cisplatin
B
gemcitabine
Intervention: gemcitabine
Outcomes
Primary Outcomes
overall survival
Time Frame: 9 months
Secondary Outcomes
- 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)
Study Sites (42)
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