Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

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

Summary:

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

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.

Trial Description

Primary Outcome:

• Primary tumour control at 2 years

Secondary Outcome:

• Rate of treatment-related grade 3 or 4 toxicity
• Other grade 3-5 adverse events
• Primary tumour failure, marginal failure, regional failure, metastatic dissemination, disease-free survival, and overall survival at 2 years
• Level of comorbidity burden on morbidity and efficacy
• Prediction of primary tumour control at 2 years and treatment-related adverse events ≥ grade 2

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 multicentre 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.

View this trial on ClinicalTrials.gov