NCT04073745

Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer

A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.

Detailed description

PRIMARY OBJECTIVES: I. Assess feasibility and toxicity of single-fraction stereotactic body radiation therapy (SBRT) in the post-operative setting. SECONDARY OBJECTIVES: I. Assess quality of life following post-operative single-fraction SBRT. II. Assess rate of in-field failures. TERTIARY OBJECTIVES: I. Assess progression free survival and overall survival following post-operative SBRT for stage III/IV non-small cell lung cancer (NSCLC). EXPLORATORY OBJECTIVES: I. Changes in the inflammatory markers. OUTLINE: Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT. After completion of study treatment, patients are followed up at 5 and 12 weeks and then periodically for up to 5 years.

Conditions

• Lung Non-Small Cell Carcinoma
• Positive Surgical Margin
• Resected Mass
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2019-12-04
• Primary completion: 2025-08-11
• Completion: 2026-03-31
• First posted: 2019-08-29
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study