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Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

NCT01463423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2024-12-19

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Maximilian Diehn, MD, PhD · Stanford University

  • Bill Loo, MD, PhD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-21
Primary Completion
2020-01-02
Completion
2022-02-07
FDA Device
Yes

Countries

  • United States
  • Canada
  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463423 on ClinicalTrials.gov