This trial is active, not recruiting.

Condition lung cancer
Treatments conventional surgery, stereotactic body radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date December 2007
End date May 2012
Trial size 33 participants
Trial identifier NCT00551369, CDR0000571744, RTOG-0618


RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor.

PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Stereotactic Body Radiation Therapy (SBRT)20 Gy per fraction for 3 fractions over 1.5 - 2 weeks for a total of 60 Gy
conventional surgery
stereotactic body radiation therapy

Primary Outcomes

Primary tumor control at 2 years
time frame: From start of treatment to 2 years.

Secondary Outcomes

Rate of treatment-related grade 3 or 4 toxicity
time frame: From start of treatment to end of follow-up.
Other grade 3-5 adverse events
time frame: From start of treatment to end of follow-up.
Primary tumor failure, marginal failure, regional failure, metastatic dissemination, disease-free survival, and overall survival at 2 years
time frame: From start of treatment to 2 years.
Level of comorbidity burden on morbidity and efficacy
time frame: From start of treatment to end of follow-up.
Prediction of primary tumor control at 2 years and treatment-related adverse events ≥ grade 2
time frame: From start of treatment to 2 years.

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types: - Squamous cell carcinoma - Adenocarcinoma - Large cell carcinoma - Large cell neuroendocrine tumor - Non-small cell carcinoma not otherwise specified - No pure type bronchoalveolar cell carcinoma - Stage I or II disease based on 1 of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging: - T1, N0, M0 - T2 (≤ 5 cm), N0, M0 - T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only) - No T2 or T3 primary tumors > 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum - No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi) - Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0 - Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer - No direct evidence of regional or distant metastases after appropriate staging studies - Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria: - Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon) - Baseline forced expiratory volume (FEV)_1 > 35% predicted - Postoperative predicted FEV_1 > 30% predicted - Diffusion capacity > 35% predicted - No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) > 50 mm Hg) at baseline - No severe pulmonary hypertension - No severe cerebral, cardiac, or peripheral vascular disease - No severe chronic heart disease - Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray - Pleural effusion that appears on chest x-ray will be allowed only after thoracotomy or other invasive procedure PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Absolute neutrophil count ≥ 1,800/mm³ - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL (transfusion allowed) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer - No active systemic, pulmonary, or pericardial infection - No weight loss > 5% for any reason within the past 3 months PRIOR CONCURRENT THERAPY: - Dose-painting delivery techniques, including intensity-modulated radiotherapy allowed - No prior radiotherapy for lung cancer - Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields - No prior chemotherapy or surgical resection for this lung cancer - No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, non-approved systemic therapy, and surgery), except at disease progression

Additional Information

Official title A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer
Principal investigator Robert D. Timmerman, MD
Description OBJECTIVES: Primary - Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer. Secondary - Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity. - Estimate the disease-free survival and the overall survival rate at 2 years. - Observe patterns of failure in the first 2 years. - Assess the level of comorbidity burden on morbidity and efficacy. - Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities OUTLINE: This is a multicenter study. Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with disease progression undergo surgical resection as salvage local therapy. After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years and then annually thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.