NCT00087438

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

A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (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 damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Determine whether treatment with stereotactic body radiotherapy results in acceptable local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II non-small cell lung cancer. Secondary * Determine treatment-related toxicity in patients treated with this therapy. * Determine disease-free survival, overall survival, and patterns of failure in patients treated with this therapy. OUTLINE: This is a multicenter study. Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity. Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic body radiation therapy

Timeline

• Start date: 2004-05-01
• Primary completion: 2010-03-01
• Completion: 2016-12-01
• First posted: 2004-07-12
• Last updated: 2019-01-16
• Results posted: 2014-04-07

Locations

2 sites across 1 country: United States