DRKS00003943已完成3 期
Treosulfan oral versus intravenous in recurrent ovarian cancer. An open-label, randomized, controlled, phase 3-b clinical trial - Treosulfan in ovarian cancer (IOM 10 / 01)
niversitätsklinikum FreiburgFrauenklinik0 个研究点目标入组 270 人开始时间: 2012年12月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •(1)Patients with a recurrence of histologically verified ovarian cancer or extra-ovarian ovarian cancer
- •(2)Patients with recurring ovarian cancer who have already undergone 1st and 2nd line therapy, meaning that this trial is equivalent to a therapy starting at the 3rd line.
- •(3)Two dimensional measurable or evaluable tumor lesion or disease progression, expressed through an increase of the tumor marker Ca 125. A distinct increase of the tumor marker parameter Ca 125 into the pathological range of > 100 U/l can be defined as progression/recurrence. The increase must however be documented as a continuous increase with at least 2 measurements. The increase should be at least 25% compared to the reference value after the preceding chemotherapy. At a Ca 125 level of > 1000 U/l, the trial treatment can be initiated immediately.
- •(4)Age = 18 years
- •(5)Minimum life expectancy 3 Months
- •(6) Karnofsky index > 50 %
- •(7)Patient information and written informed consent of the patient
排除标准
- •(1)Previous treatment with treosulfan
- •(2)Second malignancy (except basalioma or in situ cervical cancer)
- •(3)Patients with ascites/pleural effusion without evaluable or measurable tumor lesions or no increased Ca 125.
- •(4)Serious concurrent disease
- •(5)No sufficient pre-therapy bone marrow reserves, defined as:
- •leucocytes = 3,5 x 109/l
- •thrombocytes = 100 x 109/l
- •(6)Creatinine = 1,25 x upper limit of normal
- •(7)Total bilurubin = 1,25 x upper limit of normal (exception: benign conjugation disorders, e.g. Gilberts disease)
- •(8)Participation in another experimental therapy study within the past 4 weeks
- •(9)Concurrent or planned radio therapy
- •(10)Other concurrent or planned anti-neoplastic therapy
- •(11)Pregnancy or refusal of adequate contraception in women of child-bearing age for up to three months after end of therapy
研究者
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