Comparison of Quality of Life in Patients With Platinum-sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer When Treated With Treatment With Trabectedin/PLD or Standard Platinum-based Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
研究概览
简要总结
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life
详细描述
Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Patients ≥ 18 years of age
- •recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and paclitaxel were eligible to this trial.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than
- •renal function (serum creatinine 1.25 times the upper limit of normal, glomerular filtration rate greater than 60 ml/min)
- •liver function (AST/ ALT three times the upper limit of normal, bilirubin concentrations 1.25 the upper limit of normal)
- •bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count greater than 100 x 109/l).
排除标准
- •patients with more than 4 chemotherapies in medical history
- •severe cardiac disease
研究组 & 干预措施
Caelyx
40 mg/m² biweekly
干预措施: Caelyx (Drug)
结局指标
主要结局
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
时间窗: through study completion, an average of 18 months
The outcome will be measured by number of participants with reported skin toxicity PPE of CTC (Common Toxicity Criteria)-Grade I / II / III / IV. Grade I - Dysesthesia/paraesthesia tingling of hands and feet; Grade II - Discomfort in holding objects and upon walking, painless swelling and erythema; Grade III - painful erythema and swelling of palms and soles, periungual erythema and swelling; Grade IV - Desquamation, ulceration, blistering, severe pain
次要结局
- Overall Survival(for up to 3 years)