JPRN-jRCT1031190131招募中2 期
A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer - J-CROS 1502 Pancreas
Yamada Shigeru0 个研究点目标入组 82 人开始时间: 2019年11月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
相似试验
已完成
不适用
A clinical trial for efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal markerPrimary pancreatic cancerJPRN-UMIN000024690ational Institutes for Quantum and Radiological Science and Technology10
已完成
2 期
A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancerocally advanced pancreatic cancerJPRN-UMIN000024695ational Institutes for Quantum and Radiological Science and Technology32
已完成
不适用
A clinical trial for efficacy and safety of carbon-ion radiotherapy on pelvic recurrent rectal cancerRecurrent rectal cancerJPRN-UMIN000032650ational Institutes for Quantum and Radiological Science and Technology21
进行中（未招募）
2 期
Carbon-ion radiotherapy on pelvic recurrent rectal cancerJPRN-jRCT1032190165Yamada Shigeru32
已完成
不适用
A clinical trial for efficacy and safety onCarbon-ion re-irradiation for locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapyPancreatic CancerJPRN-UMIN000026541ational Institutes of Quantum and Radiological Science and Technology24