KCT0004548尚未招募未知
Safety and Efficacy of high dose inorganic seLenium for preventing chemotherapy induced pEripheral Neuropathy in platINUM sensitive recurrent ovarian, fallopian, primary peritoneal cancer: phase III randomized controlled trial (SELENIUM trial)
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- Female
入选标准
- •(1) Informed consent
- •(2) Age: 19-80 years old
- •(3) Complete or partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) or Gynecologic Cancer Intergroup criteria in epithelial ovarian cancer, fallopian cancer, or primary peritoneal cancer patients who underwent either surgery or chemotherapy and those who have recurred cancer at least six months after chemotherapy.
- •(4) Patients who have received paclitaxel chemotherapy for a minimum of 6 cycles and a maximum of 9 cycles
- •(5) ECOG performance status 0-2
- •(6) Patients with no other concurrent disease affecting overall survival
- •(7) Patients with normal hematologic, renal, and liver functions
- •(8) Patients who understand the contents of the clinical trial and are capable of participating until the end of the trial
排除标准
- •(1) Pregnancy or breastfeeding
- •(2) Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who received secondary debulking surgery.
- •(3) Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who did not receive Bevacizumab chemotherapy
- •(4) Patients with other concurrent disease that can affect overall survival (infection, hypertension, diabetes, cardiac disease, etcetera)
- •(5) Patients with underlying disease (diabetes, neuropathy, brain or bone metastasis) that can induced neuropathy
- •(6) Patients allergic to selenium
- •(7) Inappropriate patients by the researcher's decision
研究者
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