Comparison of Surgery to Stereotactic Body Radiation Therapy (SBRT) in Patients With Stage I Non-Small Cell Lung Cancer

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT05183932
Trial Phases:		Protocol IDs:	202112102-1001 (primary) NCI-2022-00200
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Siteman Cancer Center at Washington University
NCI Full Details:	http://clinicaltrials.gov/show/NCT05183932

Summary

This study compares the results of surgery to stereotactic body radiation therapy (SBRT) in patients with stage I non-small cell lung cancer (NSCLC). Both surgery and SBRT are standard treatments for this kind of lung cancer. Surgery removes the cancer but is more invasive and may have more complications. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Information gathered from this study may help researchers find out if SBRT is as effective as surgery in treating patients with stage I NSCLC.

Objectives

PRIMARY OBJECTIVES:
I. To compare disease-free survival between surgery and SBRT in stage I NSCLC patients.
II. To compare short- and long-term patient-reported outcomes between surgery and SBRT in stage I NSCLC patients.

SECONDARY OBJECTIVE:
I. To develop and validate prediction models for treatment outcomes for an individual patient with stage I NSCLC.

OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups as determined by the treating provider.

GROUP I (SURGERY): Patients undergo surgery as per standard of care on study. Patients also undergo assessment of frailty and medical chart review during screening as well as complete patient reported outcomes questionnaires pre- and post-treatment throughout study.

GROUP II (SBRT): Patients undergo SBRT as per standard of care on study. Patients also undergo assessment of frailty and medical chart review during screening as well as complete patient reported outcomes questionnaires pre- and post- treatment throughout the study.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.