A Phase II Clinical Trial of Carbon-ion Radiotherapy Combined with Gemcitabine for Locally Advanced Pancreatic Cancer
- Conditions
- ocally Advanced Pancreatic Cancer
- Registration Number
- JPRN-UMIN000026939
- Lead Sponsor
- Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1) Finding of direct invasion in gastrointestinal duct as followings: (a) Obvious finding of invasion in the stomach or duodenum in gastrointestinal endoscopy (b) Invasive lesion protruding inside of gastrointestine in imaging studies such as computed tomography (CT) 2) Ascites found by the abdominal-pelvic CT 3) Gastric or duodenal ulcer except for ulcer scar 4) Patient with metallic stent for occlusive jaundice 5) Open wound or active and intractable infection in the target lesion of irradiation 6) Severe complications such as severe stroke, diabetes, heart disease, angina, myocardial infarction developed within 3 months, severe liver dysfunction and psychologic disease 7) Active double cancer including concurrent or metachronous tumor within two years, except for lesion equivalent to carcinoma in situ or intramucosal cancer which is completely treated by local therapeutic procedure. 8) Previous history of radiotherapy for targeted lesion 9) Conditions that attending physicians consider unsuitable for this clinical study due to medical or psychological issues
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Three-year overall survival
- Secondary Outcome Measures
Name Time Method 1) Local control period 2) Progression free period 3) Incidence of adverse events