JPRN-jRCTs051180237已完成1 期
Phase II study of dynamic tumor tracking intensity-modulated radiotherapy in patients with locally advanced pancreatic cancer - No Acronym
Mizowaki Takashi0 个研究点目标入组 25 人开始时间: 2019年3月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
The first and 25th case was registered on 3rd/July/2015, and 18th/November/2018 respectively. Eighteen, three, three and one patients were registered at Kyoto university, Kobe City Medical Center General Hospital, Kyoto-Katsura Hospital, and Tokyo Metropolitan Komagome Hospital, respectively.The median age was 69 years(range; 52-77) and 13 patients were males. One-year FFLP was 75.3 %. At 1 year, LPFS, PFS and PFS were, and DDFS were 56%, 44%, 60%, respectively
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) Pancreatic cancer pathologically proven with pancreatic juice or biops. 2) Clinical stage IIA, IIB, III (UICC) 3) ECOG PS;0-1
- •4) Without previous surgical resection for pancreatic cancer or irradiation to upper abdomen
- •5) adequate oral intake
- •6) Adequate organ functions;
- •white blood cells >= 3,000/m3
- •Neutrophil>=2000/m3
- •platelets >= 100,000/m3
- •hemoglobin >= 9.0g/dl
- •AST<= 150 U/L
- •ALT<= 150 U/L
- •total bilirubin <= 2.0mg/dL
- •Creatinine <= 1.2mg/dL
- •Albumin >= 3.0 mg/dL
- •Without fever over 38 degree
- •7) diagnosed as capable of dynamic tumor tracking with inserted fiducial marker 8) Written Informed Consent
排除标准
- •1) Intersitial pneumonia or pulmonary fibrosis
- •2) previous irradiation to upper abdomen
- •3) Severe comorbidity
- •4) Pleural effusion or Ascites
- •5) Tumor invasion to stomach, duodenum or intestine
- •6) Patients with double cancer (double cancer or treated cancer with no more than 3-year disease-free period). However, carcinoma in situ or intra-mucosal cancer-equivalent lesion are not to be included in double cancer
- •7) Severe allergy history to gold
- •8) Unstable and Uncontrollable diabetic mellitus, or severe collagen disease
- •9) Woman during pregnancy or breast-feeding, patient who wish pregnancy
- •10) Psychiatric disease
- •11) Inappropriate patients for this study judged by physicians
研究者
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