Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib. Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration
研究概览
简要总结
The study includes the recruitment of patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective observational study.
详细描述
Several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown.
Sorafenib is probably the drug in which this metabolic disturbance is most frequent. The aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •Histologically documented kidney cancer or hepatocarcinoma
- •Performance status more than / equal to 2
- •Life expectancy > 12 weeks
- •in patients with recent surgery, the wound should be completely healed before taking Sorafenib
- •required initial laboratory values: absolute neutrophil count > 1500/ul Platelets > 100,000/ul., Hemoglobin > 9.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal Bilirubin less than/equal to upper limit of normal(ULN)
- •Appropriate patienty compliance
排除标准
- •myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia,
- •previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
- •significant neurologic or psychiatric diseases preventing patients to give a valid informed consent
- •Sintomatic brain metastases
- •because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded
- •patients with seizures that need medical treatment
- •History of heterologous transplantation
- •Patients with previous or active bleeding
- •Dialysis patients
- •Patients with history of primary hyperparathyroidism
- •Dysphagic patients
- •Taking more than four weeks of entry into the study of other bio-chemotherapy treatments
- •Previous treatment with Sorafenib
- •Recent (<6 months)or concomitant treatment with biphosphonate
研究组 & 干预措施
Sofanenib and Hypophosphatemia
Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib
干预措施: Sorafenib (Drug)
结局指标
主要结局
Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration
时间窗: one year
Assess the effects of sorafenib hormones involved in phosphate homeostasis
次要结局
- Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival)(one year)
- Identify metabolic differences between renal cells cancer and hepatocarcinoma(one year)
- Identify variations on bone mass during sorafenib treatment(one year)
- Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability(one year)