NCT00843726

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

A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of 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 or stage II non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer. Secondary * To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens. * To correlate outcomes and toxicities with imaging and patient and tumor biomarkers. OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). * Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting. After completion of study treatment, patients are followed for 5 years.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Arm 1 stereotactic body radiation therapy	Patients undergo 1 high-dose fraction
RADIATION	Arm II stereotactic body radiation therapy	Patients undergo 3 high-dose fractions

Timeline

• Start date: 2008-09-12
• Primary completion: 2020-05-06
• Completion: 2020-05-06
• First posted: 2009-02-13
• Last updated: 2021-06-15
• Results posted: 2021-06-15

Locations

3 sites across 1 country: United States