Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer
The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate
gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in
patients with locally advanced pancreatic cancer.
Inclusion Criteria:
- unresectable locally advanced pancreatic cancer
- no distant metastasis
- histologically confirmed adenocarcinoma of pancreas
- 18-75 of age
- ECOG performance status 0-2
- normal marrow function :
- WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- normal liver function :
--Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal
(ULN)
- normal renal function :
--Creatinine no greater than 1.5 times ULN
- signed informed consent
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Seock-Ah Im, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
H-0412-138-005
NCT ID:
NCT01396668
Start Date:
December 2004
Completion Date:
June 2011
Related Keywords:
- Pancreatic Cancer
- locally advanced
- Pancreatic Neoplasms
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