NCT01463423

Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors. While recent research has identified SABR as a promising method to increase local control (LC) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. This study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, \> 10 cc). This is a study of the procedure stereotactic ablative radiotherapy (SABR). It is not a study of a specific drug or device.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
RADIATION	iSABR, 25 Gray in 1 fraction for small peripheral tumors	Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
RADIATION	iSABR, 50 Gray in 4 fractions for medium peripheral tumors	Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
RADIATION	iSABR, 54 Gray in 3 fractions for large peripheral tumors	Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
RADIATION	iSABR, 40 Gray in 4 fractions for small central tumors	Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
RADIATION	iSABR, 50 Gray in 4 fractions for medium central tumors	Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
RADIATION	iSABR, 60 Gray in 8 fractions for large central tumors	Radiotherapy procedure for participants with large central tumors \> 30 cc.

Timeline

• Start date: 2011-10-21
• Primary completion: 2020-01-02
• Completion: 2022-02-07
• First posted: 2011-11-01
• Last updated: 2024-12-19
• Results posted: 2024-12-19

Locations

4 sites across 3 countries: United States, Canada, Japan

Regulatory

• FDA-regulated device study