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
Sponsor: Roswell Park Cancer Institute
This observational or N/A phase trial investigates Lung Non-Small Cell Carcinoma and Positive Surgical Margin and is currently ongoing. Roswell Park Cancer Institute leads this study, which shows 20 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
20 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE1 → None
-
Feb 2026 — May 2026 [monthly]
Active Not Recruiting PHASE1
-
Oct 2025 — Feb 2026 [monthly]
Active Not Recruiting PHASE1
-
Sep 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE1
-
May 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE1
▶ Show 15 earlier versions
-
Apr 2025 — May 2025 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
-
Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE1
-
Sep 2024 — Mar 2025 [monthly]
Recruiting PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1
-
Sep 2023 — Jul 2024 [monthly]
Recruiting PHASE1
-
Jun 2023 — Sep 2023 [monthly]
Recruiting PHASE1
-
Jun 2022 — Jun 2023 [monthly]
Recruiting PHASE1
-
Oct 2021 — Jun 2022 [monthly]
Recruiting PHASE1
Phase: NA → PHASE1
-
May 2021 — Oct 2021 [monthly]
Recruiting NA
-
Jan 2021 — May 2021 [monthly]
Recruiting NA
-
Jul 2020 — Jan 2021 [monthly]
Recruiting NA
-
Dec 2019 — Jul 2020 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
-
Nov 2019 — Dec 2019 [monthly]
Not Yet Recruiting NA
-
Oct 2019 — Nov 2019 [monthly]
Not Yet Recruiting NA
-
Sep 2019 — Oct 2019 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility 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.
Contact Information
- Roswell Park Cancer Institute
For direct contact, visit the study record on ClinicalTrials.gov .