JPRN-jRCTs021180042已完成2 期
The effectiveness and safety of cocurrent chemoradiation therapy for squamous cell carcinoma of vulva; P2 Study - CCRT for VSCC
Futagami Masayuki0 个研究点目标入组 18 人开始时间: 2019年3月26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
- 18
研究概览
简要总结
The antitumor effect, which is the primary endpoint, is extremely high, and the tumor control rate is higher than that of the conventional method. The 2-year survival rate is 57.1% even in stages III and IV, but long-term follow-up has not been performed, so this is for further study. Regarding safety, there were few serious adverse events and it was highly possible that it could be done safely.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old(—)
- 性别
- Female
入选标准
- •1) Patients with a histiological diagnosis of squamous cell carcinoma of vulva
- •2) Patients with measurable or evaluable lesions
- •3) First treatment case
- •4) Age is from 20 to 79 years old
- •5) ECOG Performance Status is 0-2
- •6) Major organ function is maintained
- •7) Patients who signed informed consent
排除标准
- •1) Patients who have received prior chemotherapy or/and
- •irradiation therapy
- •2) Patients with active synchronous cancer
- •3) Patients with active infection
- •4) Patients with severe complication, bronchial asthma, interstitial pneumonia, ischemic heart disease, diabetic mellitus and arrhythmia
- •5) Patients with massive pleural effusion or asites
- •6) Patients with history of hypersensitivity reaction
- •7) Patients with pregnant or lactating
- •8) Patients who is difficult to treat and follow in this study
- •9) Patients who are not eligible in this study by study chair or study co-chair.
研究者
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