Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

Detailed Description
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OBJECTIVES: Primary Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer. Secondary Determine the toxicities of this regimen in these patients. Determine the rates of regional and distant disease recurrence in these patients. Determine the progression-free and overall survival of patients treated with this regimen. Determine the changes in pulmonary function after treatment in these patients. Assess the quality of life of patients after treatment. OUTLINE: This is a multicenter, prospective study. Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Official Title
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A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: 3-dimensional conformal 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 (NSCLC) Stage I or II peripheral disease T1, N0, M0 T2 (≤ 5 cm), N0, M0 T3 (≤ 5 cm, chest wall primary tumor only), N0, M0 No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose) Hilar or mediastinal lymph nodes ≤ 1 cm considered N0 Any of the following primary cancer types: Squamous cell carcinoma Adenocarcinoma Large cell carcinoma Bronchioloalveolar cell carcinoma Non-small cell carcinoma not otherwise specified Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable) Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs No ataxia telangiectasia PATIENT CHARACTERISTICS: ECOG performance status 0-2 Not pregnant or nursing Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply) No active systemic, pulmonary, or pericardial infection No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix. Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer) PRIOR CONCURRENT THERAPY: No prior radiotherapy to the area of the primary tumor No prior or concurrent chemotherapy or immunotherapy for this tumor

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: Radiotherapy<br>3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks | Radiation: 3-dimensional conformal radiation therapy<br>* 3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor control rate at 2 years | Overall tumor control rate will be assessed at 6 years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 6 years | 
| Disease recurrence rates |  | 6 years | 
| Progression-free survival |  | 6 years | 
| Overall survival |  | 6 years | 
| Quality of life |  | 6 years | 
| Changes in pulmonary function |  | 6 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, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer