NIPH Clinical Trials Search

JRCT ID: jRCT1031190131

Registered date:12/11/2019

Carbon-ion radiotherapy and GEM for locallyadvanced pancreatic cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedpancreatic cancer
Date of first enrollment27/03/2017
Target sample size82
Countries of recruitment
Study typeInterventional
Intervention(s)Carbon-ion 55.2Gy(RBE)/12fraction/3weeks+ Gemcitabine 1000mg/m2 X 3times


Primary Outcomeoverall survival rate at 2 years
Secondary Outcometime to local failure, follow for overall survival, progression free survival, toxicity, cost-effectiveness, quality of life

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
Include criteria1) 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.
Exclude criteria1) (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

Related Information


Public contact
Name Makoto Shinoto
Address 4-9-1Anagawa Inage-ku Chiba, Chiba Chiba Japan 263-8555
Telephone +81-43-206-3306
Affiliation QST Hospital
Scientific contact
Name Shigeru Yamada
Address 4-9-1Anagawa Inage-ku Chiba, Chiba Chiba Japan 263-8555
Telephone +81-43-206-3306
Affiliation QST Hospital