jRCTs051210021招募中不适用
Investigation of clinical effect of vitamin D supplement therapy for pancreatic cancer
未提供0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 主要终点
- Pathological evaluation of the number of alfa-SMA positive cells in resected pancreatic cancer specimens
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Patients with confirmed pancreatic cancer classified as resectable pancreatic cancer who are scheduled to undergo surgery in 4 to 8 weeks after 5 to 8 weeks of preoperative systemic chemotherapy or chemoradiation.
- •(2) Age at the time of consent: 20 years or older
- •(3) PS: 0-1 (ECOG grade)
- •(4) Patients with major organ function (bone marrow, liver, kidney, lung, etc.)
- •White blood cell count: 3,500/mm3 or higher, neutrophil count: 2,000/mm3 or higher,
- •platelet count: 100,000/mm3 or higher.
- •Hemoglobin: 9.0 g/dL or higher
- •Total bilirubin: 2.0 mg/dL or less (However, 3.0 mg/dL or less for patients undergoing biliary drainage for obstructive jaundice caused by tumor)
- •AST(GOT), ALT(GPT): 150U/L or less
- •Serum creatinine level: 1.2 mg/dL or less, creatinine clearance: 60 mL/min or more (estimation by the Cockcroft-Gault formula is acceptable)
- •(5)Patients whose written consent to participate in this study has been obtained.
排除标准
- •(1) Patients with the following electrolyte abnormalities:
- •Hypercalcemia (corrected serum Ca level of 11.5 mg/dl or higher (equivalent to Grade 2 in CTCAE ver4.0))
- •Hyper PTH, PTHrPemia (above the standard value)
- •(2) Patients who are using or have taken drugs, supplements, or health foods related to bone metabolism (bisphosphonate, vitamin D, calcium, phosphorus, etc.)
- •(3) Patients who are using steroids
- •(4) Patients who have difficulty with oral treatment
- •(5) Patients with severe mental disorders
- •(6) Patients with severe drug hypersensitivity
- •(7) Patients with pregnant or wishing to pregnant
- •(8) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for the safe conduct of this study.
结局指标
主要结局
Pathological evaluation of the number of alfa-SMA positive cells in resected pancreatic cancer specimens
Number of alfa-SMA positive cells in five randomly selected fields of view at 200x in stromal cells in pancreatic cancer tissue
次要结局
- Relationship between alfa-SMA positive cells and Vitamin D administration period
- Relationship between alfa-SMA positive cells and Serum vitamin D concentration
- Relationship between alfa-SMA positive cells and Background factors
- Rate of change in bone mineral density
- Adverse events
研究者
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