Carbon-ion radiotherapy and GEM for locallyadvanced pancreatic cancer
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-jRCT1031190131
- Lead Sponsor
- Yamada Shigeru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 82
1) Radiographic diagnosis of pancreatic invasive ductal carcinoma. 2) Histological and/or cytological diagnosis of pancreas adenocarcinoma. 3) No distant metastasis. 4) Invasion of the superior mesenteric or celiac arteries. 5) No active inflammatory bowel disease nor active gastric/duodenal ulcer. 6) Age 20-80 years. 7) Performance Status (ECOG) of 0-2. 8) No prior surgical nor radiological treatment for pancreatic cancer. 9) Meet the criteria listed below, within 28 days of registration. (a) WBC>=3500 /mm3(for patients treated with prior chemotherapy : WBC>=2000 /mm3 ), (b) Hb>=9.0 g/dl, (c) Plt>=100000 /mm3, (d) Alb>=3.0 g/dl, (e) T-bil=<3 mg/dl, (f) GOT(AST)=<150 IU, (g) GPT(ALT)=<150 IU, (h) Cre=<1.2 mg/dl 10) Written consent form of the patient.
1) (a) Invasion to the mucosal layer of duodenum or stomach by endoscopic diagnosis (b) Displacement of digestive tracts by radiographic diagnosis. 2) Exist of ascites. 3) Placement of a metal stent for relief of biliary obstruction. 4) Prior treatment for pancreatic cancer for longer than 90days. 5) Active interstitial pneumonitis or pulmonary fibrosis. 6) Active and Severe infection in the irradiation field. 7) Severe co-existing disorders (diabetes mellitus, heart failure and so on) 8) History of other malignancies within 2 years. 9) History of abdominal radiotherapy. 10) Severe allergy to gemcitabine. 11) During pregnancy, or during lactation. 12) Any medical, psychological or other reasons that the investigator think those as ineligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival rate at 2 years
- Secondary Outcome Measures
Name Time Method time to local failure, follow for overall survival, progression free survival, toxicity, cost-effectiveness, quality of life