NCT00039039Unknown3 期
Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy74 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2000年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 74
- 主要终点
- Overall survival rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use 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. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel.
- Compare the 1-year survival rate and mean survival time in patients treated with these regimens.
- Compare the objective response rate and local control in patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the safety profile and toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then proceed to randomized treatment.
- Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks.
- Arm II: Patients receive radiotherapy 5 days a week for 7 weeks. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC)
- •Locoregionally advanced unresectable disease
- •Previously untreated
- •Measurable disease
- •No involvement of supraclavicular lymph nodes
- •No cytologically positive pleural or pericardial effusion
- •No invasion to the wall of the esophagus or the cardiac ventricle
- •No bone marrow involvement
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC greater than 4,000/mm^3
- •Absolute neutrophil count greater than 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •Bilirubin less than upper limit of normal (ULN)
- •AST and ALT less than 2.5 times ULN
- •Alkaline phosphatase less than 5 times ULN
- •No hepatic abnormalities
- •Creatinine less than ULN
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No cardiac insufficiency
- •No uncontrolled arrhythmia
- •FEV1 greater than 1 L
- •DLCO at least 30% predicted
- •No pneumonia
- •No other non-disease-related pulmonary complications
- •No more than 10% of total weight loss over the past 6 months
- •No other disease that would preclude study
- •No peripheral neuropathy grade 3 or greater
- •No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No familial, geographic, or psychological condition that would preclude study
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior systemic chemotherapy
- •Endocrine therapy:
- •No concurrent endocrine therapy
- •Radiotherapy:
- •No prior radiotherapy for NSCLC
- •See Disease Characteristics
- •No prior complete resection of tumor
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall survival rate
次要结局
- Safety profile, in terms of acute and delayed toxicity
- Tolerability
- One-year survival rate and mean survival time
- Objective response rate and local control
研究者
研究点 (74)
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