Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer. Secondary To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens. To correlate outcomes and toxicities with imaging and patient and tumor biomarkers. OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting. After completion of study treatment, patients are followed for 5 years.

Official Title
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A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: Arm 1 stereotactic body radiation therapy
* Radiation: Arm II stereotactic body radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed non-small cell lung cancer T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded) Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection Age >= 18 Exclusion Criteria: Prior thoracic radiation therapy T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement Node positive or metastatic disease Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree. No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly) Pregnant or unwilling to use adequate contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). | Radiation: Arm 1 stereotactic body radiation therapy<br>* Patients undergo 1 high-dose fraction<br>|
| Experimental: Arm II<br>Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. | Radiation: Arm II stereotactic body radiation therapy<br>* Patients undergo 3 high-dose fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AE Grade 3 or Higher Toxicity | Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse. | 1year | 
| Overall Survival | Median overall survival | 5 years | 
| Correlation Between Blood and Serum Markers and Survival and Toxicity |  | 4 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