Status:
COMPLETED
Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer
Lead Sponsor:
Hamamatsu University
Conditions:
Esophageal Cancer
Squamous Cell Carcinoma
Eligibility:
All Genders
20-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carc...
Detailed Description
The tumor stages and disease grades were classified according to the TNM classification (sixth edition) of the International Union against Cancer (UICC). These were determined conventionally by comput...
Eligibility Criteria
Inclusion
- newly diagnosed cases histologically as squamous cell carcinoma,
- a performance status 0 to 2,
- white blood cells \>3,000/microL,
- platelets \>100,000/microL,
- serum total bilirubin \<2.0 mg/dl,
- serum transaminase \<3 times the upper normal limit,
- serum creatinine \<1.5 mg/dl,
- creatinine clearance \>60 ml/min
Exclusion
- serious cardiac disease
- prior chemotherapy and radiotherapy
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00197444
Start Date
January 1 2003
End Date
December 1 2008
Last Update
February 20 2009
Active Locations (1)
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1
First Department of Medicine, Hamamatsu University School of Medicine
Hamamatsu, Japan, 431-3192