NCT01185639

Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer

Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line chemotherapy is feasible, safe, provides durable local control of treated lesions and improves time to progression compared to historical controls. Patients are eligible for enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.

Conditions

• Non-Small-Cell Lung Carcinoma
• Liver Cancer
• Adrenal Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic body radiation therapy	For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques

Timeline

• Start date: 2010-08-01
• Primary completion: 2016-06-27
• Completion: 2016-06-27
• First posted: 2010-08-20
• Last updated: 2019-11-29
• Results posted: 2019-11-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study