Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 132
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy with or without adjuvant paclitaxel and carboplatin.
Secondary
- Compare the objective response rate in patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Stage II or III disease
- •Not amenable to surgery
- •Measurable or evaluable disease
- •No T4 apical localization
- •Lesions able to be covered in a 60 Gy minimum volume of radiation
- •No pleural effusion
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •Creatinine < 1.25 times ULN
- •Cardiovascular
- •No unstable heart disease
- •No ventilation dysfunction that would preclude radiotherapy
- •No weight loss of 15% or more within the past 2 months
- •No uncontrolled infection
- •No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 6 months since prior neoadjuvant chemotherapy
- •No prior adjuvant chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •No prior radiotherapy
- •Not specified
- •No other concurrent clinical trial participation
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Toxicity
- Objective response rate
- Overall survival