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Randomized phase II study comparing Gemcitabine chemoradiotherapy with Gemcitabine chemotherapy for unresectable locally advanced pancreatic cancer.

Phase 2
Conditions
nresectable locally advanced pancreatic cancer.
Registration Number
JPRN-UMIN000012253
Lead Sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
110
Inclusion Criteria

Not provided

Exclusion Criteria

1) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. 2) Watery diarrhea 3) Severe infection 4) Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5) Massive pleural or abdominal effusion. 6) Metastasis to central nervous system. 7) Active synchronous or metachronous malignancy other than carcinoma in situ. 8) Regular use of frucitocin, fenitoin or warfarin 9) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 10) Severe mental illness 11) Patients who are judged inappropriate for the entry into the study by the investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Two year survival rate
Secondary Outcome Measures
NameTimeMethod
Progression free survival(PFS) Overall Survival(OS) Adverse events Response rate
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