CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 256 enrolled
Drug / intervention
iSABR, 25 Gray in 1 fraction for small peripheral tumors +5 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01463423N/ACompleted
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Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Stanford University·interventional·Posted Nov 1, 2011·Updated Dec 19, 2024

In Brief

A clinical study evaluating iSABR, 25 Gray in 1 fraction for small peripheral tumors, iSABR, 50 Gray in 4 fractions for medium peripheral tumors, and 4 other interventions for Non-small Cell Lung Cancer (NSCLC). Completed, enrolled 256 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer (NSCLC)
CountriesCanada, Japan, United States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2011
Enrollment StartOct 21, 2011
Primary CompletionJan 2, 2020
Study CompletionFeb 7, 2022
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 14.7 years ago

Interventions

iSABR, 25 Gray in 1 fraction for small peripheral tumorsradiation

Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.

iSABR, 50 Gray in 4 fractions for medium peripheral tumorsradiation

Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.

iSABR, 54 Gray in 3 fractions for large peripheral tumorsradiation

Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.

iSABR, 40 Gray in 4 fractions for small central tumorsradiation

Radiotherapy procedure for participants with small central tumors ≤ 10 cc.

iSABR, 50 Gray in 4 fractions for medium central tumorsradiation

Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.

iSABR, 60 Gray in 8 fractions for large central tumorsradiation

Radiotherapy procedure for participants with large central tumors \> 30 cc.