JPRN-jRCTs071230118尚未招募3 期
Efficacy and Safety of Low Molecular Weight Hyaluronate gel spacer for Radiation Therapy of Gynecological Cancer
Miyata Yusaku0 个研究点目标入组 95 人开始时间: 2024年2月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 95
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
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1) Patients with gynecological cancer (cervical cancer, uterine body cancer, vaginal cancer, vulvar cancer) who are eligible for radical radiotherapy and meet any of the following conditions (i) to (iii)
- •(i) Adenocarcinoma or adenosquamous carcinoma
- •(ii) Extends more than 2 cm from the vaginal fornix to the lower part of the vagina and requires the use of a cylinder applicator.
- •(iii) Patients with a high radiation dose to the rectum, bladder, sigmoid colon, or small intestine after initial high-dose-rate brachytherapy without hyaluroniate gel injection and who are expected to have a high rate of adverse reactions if the treatment is continued.
- •2) Patients must be at least 18 years old.
- •3) Patients with or without symptoms
- •4) Patients with any pre-existing medical conditions (except in the case of an allergy to hyaluronate gel)
- •5) No contrast media if renal dysfunction (eGFR<50 ml/min/1.73 m2) or contrast media allergy
- •6) Threshold values should not be set based on clinical laboratory values, etc.
- •7) The patient may consent to the procedure. However, if the patient has expressed the intention to consent but is unable to sign, a guardian, guarantor, or legal representative may sign in place of the patient's signature.
排除标准
- •1) Patients who are eligible for palliative radiation therapy.
- •2) Patients who do not have the capacity to consent.
- •3) Patients with allergic symptoms to hyaluronate gel.
研究者
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