JPRN-jRCTs061220053招募中2 期
A pilot study of low-concentration hydrogen peroxide exposure radiotherapy for low radiosensitive tumors and bulky tumors that are unresectable and ineligible for standard chemotherapy
Tamaki Yukihisa0 个研究点目标入组 10 人开始时间: 2022年8月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Histologically diagnosed as Non-Hematologic Malignancies
- •2. It satisfies one of the following
- •Low radiosensitive tumors (adenocarcinoma, sarcoma, melanoma, hepatocellular carcinoma, renal cell carcinoma)
- •Bulky tumor >= 5cm (regardless of radiosensitivity)
- •3. Unresectable malignant tumor
- •4. Ineligible for standard chemotherapy and no alternative curative treatment
- •5. Measurable lesions exist
- •6. Age 20 years or older on the date of informed consent
- •7. ECOG performance status (PS) of 0-3.
- •8. The latest laboratory test within 28 days prior to enrollment
- •a. WBC >=2000/micro L
- •b. Platelet >=50000 / micro L
- •c. Total bilirubin <=3.0 mg/dL
- •d. AST <=150 U/L
- •e. ALT <=150 U/L
- •f. SpO2 (room air) >=90%
- •9. Written informed consent
排除标准
- •1. Hypersensitivity to hydrogen peroxide, sodium hyaluronate, Lidocaine or amide type local anesthetic
- •2. Uncontrollable infection
- •3. Disseminated intravascular coagulation
- •4. Unable to maintain the rest position for 20 minutes
- •5. Pregnant or possibly pregnant woman, or man who wants pregnancy of his partner
- •6. Psychological disorder difficult to participate in the study
- •7. Interstitial lung disease or Pulmonary fibrosis
研究者
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