JPRN-jRCTs021190022招募中2 期
Prospective study about the safety of radiotherapy for gynecologic tumors using ethyl ester of iodinated poppy-seed oil fatty acid - The study of radiotherapy for gynecological tumors using lipiodol
mezawa Rei0 个研究点目标入组 50 人开始时间: 2020年2月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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 <= 80age old（—）
- 性别
- Female
入选标准
- •(1) Cervical cancer, Vaginal cancer
- •(2) Patients with indications for definitive radiotherapy
- •(3) Age between 20 and 80 years old
- •(4) ECOG performance status 0-2
- •(5) No prior abdominopelvic irradiation
- •(6) It is possible to stop taking or do not intake any anticoagulant or antiplatelet
- •(7) Patients with sufficient organ function
- •- neutrophil count greater than 2,000/mm3
- •- hemoglobin greater than 8g/dL
- •- platelets greater than 50,000/mm3
- •- albumin greater than 3.0 g/dL
- •- total bilirubin lower than 2.0mg/dL
- •- AST (GOT) and ALT (GPT) lower than 150 IU/L
- •-serum creatinine lower than 1.2mg/dL
- •(8) Patient must provide study-specific informed consent prior to study entry
排除标准
- •(1) Severe comorbidities (such as heart failure, renal failure, hepatic failure, respiratory dysfunction, lymph duct obstruction, poorly controlled diabetes and poorly controlled hypertension)
- •(2) Active thyroid disease
- •(3) Pyrexia of 38 degrees centigrade or higher.
- •(4) An allergy to iodine drugs
- •(5) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
- •(6) Psychiatric comorbidities or problems hinders enrollment of the study
- •(7) Attending physician believes the patient is not suitable for the study
研究者
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