NCT00960999

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

A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized 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. It is not yet known which regimen of stereotactic body 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 non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment with single fraction vs multiple fraction stereotactic body radiotherapy in medically inoperable patients with stage I peripheral non-small cell lung cancer. Secondary * To estimate the 1-year primary tumor control rate in these patients. * To estimate the 1-year overall survival and disease-free survival rate of these patients. * To assess FDG-PET (fluorodeoxyglucose - positron emission tomography) standardized uptake value changes as a measure of treatment response and outcomes. * To determine pulmonary function changes by treatment arm and response. * To determine the association between biomarkers and primary tumor control and/or ≥ grade 2 radiation pneumonitis. OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2 treatment arms. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Single-fraction stereotactic body radiation therapy (SBRT)	34 Gy in 1 fraction to the prescription line at the edge of the planning target volume (PTV). The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and \< 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least \< 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be \< 10%.
RADIATION	Multiple-fraction stereotactic body radiation therapy (SBRT)	48 Gy in four 12 Gy fractions to the prescription line at the edge of the planning target volume (PTV). Treatments are given on 4 consecutive calendar days, but at least 18 hours apart. The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and \< 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least \< 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be \< 10%.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-08-01
• Completion: 2018-05-14
• First posted: 2009-08-18
• Last updated: 2020-03-04
• Results posted: 2014-11-04

Locations

38 sites across 2 countries: United States, Canada