Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Determination of progression free survival after 12 months of FU
Determination of total survival, response and quality of life
详细描述
In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.
It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
- •Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
- •All patients will provide written informed consent
排除标准
- •Patients with more than two chemotherapies in their history
- •Progress less than six months after completion of primary standard therapy
- •Simultaneous or planned radiation
- •Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
- •Patients with infection
- •Patients who are pregnant or breast feeding
研究组 & 干预措施
1
Topotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d.
干预措施: Topotecan (Drug)
结局指标
主要结局
progression-free survival
时间窗: after 1 year-follow-up
次要结局
- overall survival, efficacy and tolerability of the regimes and quality of life(during study and follow-up)