Status:
COMPLETED
Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Osaka Medical Center for Cancer and Cardiovascular Diseases
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pa...
Detailed Description
When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already u...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
- Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below.
- Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.)
- Involving over the merging section of portal-SMV.
- No distal metastasis with diagnostic imaging.
- Confirmed by CT image performed with in four weeks before registration.
- Performance Status:0-1(ECOG)
- Patients of age =\>20 and 80\>
- sufficient organ functions
- neutrophils\>=1,500/mm3
- platelets\>=100,000/mm3
- hemoglobin\>=9.0g/dl
- AST(GOT)/ALT(GPT) \<=150IU
- total bilirubin \<=2.0mg/dl, (or \<=3.0mg/dl if biliary drainage were present)
- serum creatinine \<= 1.2mg/dl
- creatinine clearance\>=60ml/min
- Life expectancy more than 3 months.
- Written informed consent.
Exclusion
- Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
- Watery diarrhea
- Severe infection
- Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
- Massive pleural or abdominal effusion.
- Metastasis to central nervous system.
- Active synchronous or metachronous malignancy other than carcinoma in situ.
- Regular use of flucytosine, fenitoin or warfarin
- Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
- Severe mental illness
- Patients who are judged inappropriate for the entry into the study by the investigator.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01430052
Start Date
April 1 2009
End Date
September 1 2015
Last Update
November 21 2017
Active Locations (1)
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1
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511