High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this study.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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: Age Not specified Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal 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 Pulmonary FEV_1 at least 1.2 L OR DLCO at least 60% Other 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 Surgery No prior therapeutic surgery to the chest area Other No other prior therapy to the chest area
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer