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NCT01463423 · ClinicalTrials.gov registry record · NA

Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

A NA study, sponsored by Stanford University.

Completed
Registry status
NA
Development phase
256
Enrollment target

NCT01463423: Completed NA study, sponsored by Stanford University.

NCT01463423 is a NA study that has completed, run by Stanford University. The registered enrollment target is 256 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01463423, a NA study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
NA
Development phase
256 participants
Enrollment target

Study 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.

Primary Outcome

Local tumor control was assessed by CT, PET-CT, and, if appropriate, biopsy. The outcome was reported as the number of lesions that maintained tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment.

Interventions

  • RADIATION iSABR, 25 Gray in 1 fraction for small peripheral tumors
  • RADIATION iSABR, 50 Gray in 4 fractions for medium peripheral tumors
  • RADIATION iSABR, 54 Gray in 3 fractions for large peripheral tumors
  • RADIATION iSABR, 40 Gray in 4 fractions for small central tumors
  • RADIATION iSABR, 50 Gray in 4 fractions for medium central tumors

Trial Details

FieldValue
Enrollment Target 256 participants
Start Date 2011-10-21
Est. Completion 2022-02-07
Phase NA
Stanford University

1,744 total trials

What the finished NCT01463423 record still lists

NCT01463423 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 5 interventions - of which iSABR, 25 Gray in 1 fraction for small peripheral tumors is the first listed.

NCT01463423 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01463423 about?

NCT01463423 is a clinical study titled "Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)". 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. W...

What is the current status of trial NCT01463423?

This trial is currently completed. It is a NA study. The enrollment target is 256 participants. The study started on 2011-10-21. Estimated completion is 2022-02-07.

What interventions are being tested in trial NCT01463423?

The interventions under investigation include: iSABR, 25 Gray in 1 fraction for small peripheral tumors (RADIATION), iSABR, 50 Gray in 4 fractions for medium peripheral tumors (RADIATION), iSABR, 54 Gray in 3 fractions for large peripheral tumors (RADIATION), iSABR, 40 Gray in 4 fractions for small central tumors (RADIATION), iSABR, 50 Gray in 4 fractions for medium central tumors (RADIATION).

Who is sponsoring clinical trial NCT01463423?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01463423's enrollment target sits among peer trials

256 404th of 2000 higher than 1,594 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01463423, the US trial registry maintained by the National Library of Medicine. NCT01463423 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.