Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. PURPOSE: Phase I trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage I, stage II, or stage III non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the maximum dose of external beam irradiation deliverable using conformal 3-dimensional treatment planning in patients with non-small cell lung cancer. Determine the feasibility and efficacy of 3-dimensional treatment planning in delivering high doses of external beam radiotherapy to these patients. Determine whether computer-generated dose-volume histograms and normal tissue complication probability models can predict the degree of pulmonary toxicity resulting from external beam radiotherapy. Determine the relationship between dose of external beam radiotherapy and the degree of pulmonary function change. OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks. Cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 20% of patients experience dose-limiting toxicity. Patients are followed at 1 month and then every 4 months thereafter. PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 3 years.

Official Title
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A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR 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 Clinical stage T1-4, N0-2, M0 Clinical stage T1-2, N0-1 must be medically inoperable No distant metastases on history and physical exam, CBC, screening profile, CT or MRI of brain, CT of chest and abdomen (including adrenals and liver), and bone scan No pleural effusions Atelectasis not clearly distinguishable from tumor mass allowed provided all tumor and atelectasis together represent a volume that can be safely treated to the total dose delivered to gross disease Diffuse pulmonary infiltrates thought to represent benign disease allowed only if representative lesion samples are proven by biopsy or cytology not to contain cancer No diffuse bronchoalveolar carcinoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical carcinoma No other medical illness that cannot be adequately controlled with appropriate therapy or that is considered severe enough to preclude a radical treatment approach PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for lung cancer Chemotherapy No prior chemotherapy for lung cancer Endocrine therapy No prior endocrine therapy for lung cancer Radiotherapy No prior radiotherapy for lung cancer Surgery No prior surgery for lung cancer

Ages Eligible for Study
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Minimum Age: 18 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: external beam radiotherapy<br>Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks. | Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum dose of external beam irradiation |  | 2 years | 

 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, stage IIIB non-small cell lung cancer