TCTR20210204013已完成2 期
Saccharomyces boulardii for Preventing Acute Radiation Enteritis in Uterine Cervical Cancer
Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University0 个研究点目标入组 60 人开始时间: 2021年2月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 18 Years 至 70 Years（—）
- 性别
- Female
入选标准
- •1. ECOG performance status 0-1
- •2. Locally advanced uterine cervical cancer FIGO version 2018 stage IB3, IIA2, IIB, IIIA, IIIB, IIIC1, IVA (bladder only)
- •3. Histologically confirmed of squamous cell carcinoma, adenocarcinoma, adenosquamous of cervix
- •4. Baseline laboratory tests are in the normal ranges. (White blood cell not less than 3000 per mL, Absolute neutrophil not less than 1500 per mL, Creatinine clearance not less than 50 mL per min)
- •5. The participant or legal representative provides the written informed consent for the study.
排除标准
- •1. Any previous pelvic radiotherapy
- •2. Prior diagnosis of Crohn disease or ulcerative colitis
- •3. Patients who are pregnant or lactating
- •4. Metastatic disease to paraaortic lymph node area, distant metastatic disease or locoregional recurrence.
- •5. Prior allergy to probiotic or medication(s) used in the study.
- •6. Active autoimmune disease that required medication within 2 years.
- •7. Use of immune suppressive medication within 2 months before accrual.
- •8. Known disease or condition that would interfere with the cooperation of the study.
- •9. Poor communication or cooperation as the treating physician judgement
- •10. Rectal invasion of primary tumor
- •11. Paraaortic lymph node metastasis
- •12. Prior chemotherapy
研究者
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