A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 14
- 主要终点
- Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
研究概览
简要总结
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated.
- Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%).
- Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days a week for 6 weeks.
- Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-7 weeks.
- Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-6.5 weeks.
Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 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
- •Medically inoperable stage I or II disease
- •Stage III disease eligible provided the following are true:
- •No supraclavicular node involvement
- •No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement
- •No distant metastasis
- •No malignant pleural or pericardial effusion
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No prior myocardial infarction
- •No prior complete bundle branch block
- •No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease
- •No clinically significant cardiac arrhythmias
- •No congestive heart failure
- •FEV_1 at least 1.2 L OR
- •DLCO at least 60%
- •No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
- •No intractable or uncontrolled infection
- •No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up
- •Able to tolerate a course of radiotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy
- •No prior anthracyclines
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to the chest area
- •No prior therapeutic surgery to the chest area
- •No other prior therapy to the chest area
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
次要结局
- Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
- Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter