Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.
详细描述
This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of NSCLC stage IIIA-B.
- •Nonresectable or medically inoperable patients.
- •No prior chemo- or radiotherapy for NSCLC.
- •FEV1 > 1 l or > 40% and CO diffusion capacity > 40%.
- •Patient compliance and geographic proximity that allow adequate follow-up.
- •Adequate bone marrow reserve: WBCC >3.0, platelets >100, haemoglobin >
- •Written informed concent.
- •Effective use of contraception.
排除标准
- •Excessive weight loss within 6 months (> 10%).
- •Supraclavicular nodes.
- •Apical tumors-pancoast.
- •T4 tumors with separate manifestations in different lobes.
- •Evidence of active serious infections.
- •Inadequate liver function.
- •Inadequate kidney function.
- •Pregnancy.
- •Breast feeding.
- •Serious concomitant systemic disorder.
- •Second primary malignancy the last 5 years.
结局指标
主要结局
Progression free survival
时间窗: 36 monts after randomization
次要结局
- Numbers of patients without progression of locoregional disease(36 months after randomization)
研究者
Ass. Prof. Jan Nyman
Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden
Swedish Lung Cancer Study Group