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临床试验/JPRN-jRCTs021180042
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

发起方
Futagami Masayuki

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