NCT00003803终止3 期
A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III
European Organisation for Research and Treatment of Cancer - EORTC34 个研究点 分布在 5 个国家目标入组 158 人开始时间: 1999年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 158
- 试验地点
- 34
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 used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare survival, disease-free survival, local control, and pattern of recurrence in patients with unresectable stage I, II, or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin.
- Compare the acute and late toxic effects of these regimens in these patients.
- Determine the quality of life of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.
- Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.
Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer
- •Stage I, II, III (T1-4, N0-3, M0)
- •No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes
- •Medically inoperable or unresectable
- •No pleural or pericardial effusion (except with repeated negative cytology)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •ECOG 0 or 1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 6.8 g/dL
- •No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours
- •Not specified
- •Creatinine no greater than 1.25 times normal OR
- •Creatinine clearance greater than 70 mL/min
- •Cardiovascular:
- •No evidence of heart failure
- •No myocardial infarction within the past 6 months
- •No superior vena cava syndrome
- •FEV1 at least 1 L
- •No pre-existing fibrotic lung disease
- •No postobstructive pneumonia preventing exact delineation of tumor volume
- •Diffusion capacity at least 60%
- •No weight loss of more than 10% in the past 3 months
- •No uncontrolled infection
- •No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to the chest
- •Maximum length of the esophagus receiving 40 Gy no greater than 18 cm
- •Maximum length of the esophagus receiving 66 Gy no greater than 12 cm
- •Must limit the spinal cord dose to a maximum of 50 Gy
- •Must be able to exclude 25% of the heart from the boost volume
- •Not specified
- •No other concurrent experimental medications
排除标准
- 未提供
研究者
研究点 (34)
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