A Multi-Centre Phase II Study Using Carboplatin AUC-10 for Metastatic Seminoma With IGCCCG Good Prognosis Disease-Therapy Directed by Initial Metabolic Response on PET-CT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- 2 - Year Progression Free Survival
研究概览
简要总结
This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis.
- •Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min.
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-
- •Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable).
- •Males aged ≥18 and ≤75 years.
- •Able to give written informed consent prior to study entry.
- •Patients must be sterile or agree to use adequate contraception during the period of therapy.
排除标准
- •Metastatic seminoma with any non-pulmonary visceral metastases.
- •Raised Alpha-fetoprotein.
- •Any previous chemotherapy or radiotherapy.
- •Currently enrolled in any other investigational drug study.
- •Other malignancy except basal cell.
研究组 & 干预措施
Carboplatin AUC-10
干预措施: Carboplatin AUC-10 (Drug)
结局指标
主要结局
2 - Year Progression Free Survival
时间窗: 2 years
Number of participants progression free 2 years after registration.
次要结局
- Metabolic Response Rate(21 days)
- Overall Survival(2 years)