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临床试验/NCT00312988
NCT00312988已完成3 期

Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer

North Eastern German Society of Gynaecological Oncology2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2000年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
450
试验地点
2
主要终点
overall survival

研究概览

简要总结

Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

详细描述

In Germany ovarian cancer belongs to the most frequently forms of cancer in the female population. The prognosis for women with a platin refractory ovarian cancer is very bad. The median survival time amounts for less a year. Especially in this palliative situation therapies regarding efficacy as well as quality of life are needed. in Germany Topotecan is approved since 1996 for patients after previous treatment with platin, the rare non-hematological side-effects making it interesting for a palliative therapy. Since best results in a chemo-therapeutical treatment are commonly obtained with the combination of two or more cytostatic agents this study tests a Topotecan Monotherapy and two Topotecan combinations. Both combination agents show efficacy alone against solid cancer using from Topotecan different mechanism resulting in different main side effects. Total survival, remission rates, time ti progression and quality of life are the main criteria investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient with recurrent ovarian cancer
  • Second-line chemotherapy
  • > = 18 years of age
  • ECOG < = 2

排除标准

  • ECOG > 2
  • Patients with more than one chemotherapy in anamneses

结局指标

主要结局

overall survival

次要结局

  • determining adverse effects
  • quality of life
  • time to progression

研究者

研究点 (2)

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