Carbon-ion radiotherapy and GEM for locallyadvanced pancreatic cancer

JRCT ID: jRCT1031190131

Registered date:12/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 27/03/2017
• Target sample size: 82
• Study type: Interventional

Intervention(s)

Carbon-ion 55.2Gy(RBE)/12fraction/3weeks+
Gemcitabine 1000mg/m2 X 3times

Outcome(s)

• Primary Outcome: overall survival rate at 2 years
• Secondary Outcome: time 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
• Gender: Both
• Include criteria: 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.
• Exclude criteria: 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

Related Information

• Primary Sponsor: Yamada Shigeru
• Secondary ID(s): UMIN000024695