Comparison of Quality of Life (QoL) Between Trabectedin/PLD and Standard Platinum-based Therapy in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 21
- 主要终点
- Difference in Quality of Life (QoL)
研究概览
简要总结
This is a multicenter, randomized, controlled, open-label study including patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer.
The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD with other standard platinum-based chemotherapy in platinum-sensitive disease.
详细描述
This is a multicenter, randomized, controlled, open-label study including patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer.
The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD with other standard platinum-based chemotherapy in platinum-sensitive disease.
Patients with recurrent, platinum-sensitive, ovarian, fallopian tube and peritoneal cancer will be stratified according to surgery for relapse (R0 vs. R1/2 resection) vs. no surgery in the same setting and age (< 75 years vs. ≥ 75 years), and randomized 1:1 to receive either trabectedin/PLD (Arm A) or one of 3 platinum-based standard therapies without bevacizumab (Arm B, "other standard therapy"). In case of randomization to "other standard therapy", the investigator has the choice between carboplatin/PLD, carboplatin/gemcitabine and carboplatin/paclitaxel. Patients in both treatment arms will receive chemotherapy up for 6 cycles or until disease progression (PD), unacceptable toxicities or patient's wish to stop therapy, whichever occurs first.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
干预措施: Trabectidin (Yondelis) (Drug)
Arm B
- Carboplatin/PLD
- Carboplatin/Gemcitabine
- Carboplatin/Paclitaxel Patients will be treated for 6 cycles or until PD, unacceptable toxicity or patient's wish to discontinue, whichever occurs first.
干预措施: Trabectidin (Yondelis) (Drug)
结局指标
主要结局
Difference in Quality of Life (QoL)
时间窗: 12 month (from baseline to end of treatment)
The difference in QoL is defined as change of the mean score of the Trial Outcome Index (TOI) from baseline (TOI at randomization) compared to end of treatment (TOI at EOT) and is calculated as follows: Difference TOI = TOI at EOT - TOI at baseline. 1. equals to 0 meaning no change in quality of life at EOT compared to baseline 2. \>0 meaning a detoriated quality of life at EOT compared to baseline. (The higher the number, the higher the detoriation.) 3. \<0 meaning an improved quality of life at EOT compared to baseline. (The lower the number, the higher the improvement.) TOI is calculated as mean of subscores concerning functional scales (e.g. physical function) and symptomal scales (e.g. body image, chemotherapy side effects, attitude to disease/treatment). Scores of each scale are transformed and ranges between 0-100. High scores for functional scales and symptomal scales meaning a low level of functioning and a high level of symptomatology/problems, respectively.
次要结局
- Progression-free Survival(18 month)
- Overall Survival(through study completion, up to 3 years)