NCT03348748

Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and feasibility of combining single fraction stereotactic body radiation therapy (SBRT) followed by surgery, in thoracic malignancies. SECONDARY OBJECTIVES: I. To estimate overall survival (OS) and progression-free survival (PFS) after single fraction SBRT followed by surgery, in thoracic malignancies. II. To define any differences in quality of life/toxicity following SBRT based on tumor location/stage/tumor type. TERTIARY OBJECTIVES: I. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies. OUTLINE: Patients are assigned to 1 of 3 studies. STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.

Conditions

• Stage I Non-Small Cell Lung Cancer AJCC v7
• Stage IA Non-Small Cell Lung Carcinoma AJCC v7
• Stage IB Non-Small Cell Lung Carcinoma AJCC v7
• Stage II Non-Small Cell Lung Cancer AJCC v7
• Stage IIA Non-Small Cell Lung Carcinoma AJCC v7
• Stage IIB Non-Small Cell Lung Carcinoma AJCC v7
• Stage IIIA Non-Small Cell Lung Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
DRUG	Stereotactic Body Radiation Therapy	Undergo lowest-dose of SBRT
DRUG	Stereotactic Body Radiation Therapy	Undergo lowest- or higher-dose of SBRT
DRUG	Stereotactic Body Radiation Therapy	Undergo highest-dose of SBRT
PROCEDURE	Thoracic Surgical Procedure	Undergo thoracic surgery

Timeline

• Start date: 2017-12-18
• Primary completion: 2021-07-12
• Completion: 2025-11-10
• First posted: 2017-11-21
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study