Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cisplatin Based First Line Chemotherapy: the SYRINGES Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
Rationale: a number of recent phase III randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. The survival advantages observed in the studies persist for months after the active treatment with LMWHs. Therefore these survival advantages are thought to be due to effects of LMWHs on tumor cell biology.
First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination has been widely studied, and is amongst the most active treatments currently available. The occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced NSCLC.
详细描述
Purpose: the aim of this study is to evaluate the potential beneficial antitumoral effect of LMWH enoxaparin in patients with locally advanced or metastatic NSCLC determined by the time to progression, the overall survival and the symptom control. LMWH will be added to a first line cisplatin-based chemotherapy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic NSCLC (stage IIIB or IV)
- •Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
- •At least one measurable lesion according to RECIST criteria
- •Good performance status
- •Adequate haematological, renal and liver function
- •Written informed consent
排除标准
- •Previous chemotherapy for NSCLC
- •Brain metastasis
- •History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
- •Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
- •Concomitant therapy with an anti-angiogenesis agent
- •Contra-indication for LMWH
- •Life expectancy of < 3 months
- •Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol
研究组 & 干预措施
Arm A
Chemotherapy without LMWH
干预措施: cisplatin + docetaxel (Drug)
Arm B
Chemotherapy with LMWH
干预措施: cisplatin + docetaxel + enoxaparin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: during chemotherapy and follow-up
次要结局
- Overall Survival(during chemotherapy and follow-up)
- Best Overall Response(during chemotherapy and follow-up)
- Incidence of total documented thromboembolic and hemorrhagic events(during chemotherapy and follow-up)
- Overall safety and tolerability(during chemotherapy and follow-up)
- Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)(during chemotherapy and follow-up)
研究者
Ethisch Comité UZ Antwerpen
Thoracale Oncologie Groep Antwerpen
University Hospital, Antwerp