Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiediSABR, 25 Gray in 1 fraction for small peripheral tumors and iSABR, 50 Gray in 4 fractions for medium peripheral tumors

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 19, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Stanford University

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: Stanford University
Interventions being studied: 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; Radiation: iSABR, 60 Gray in 8 fractions for large central tumors

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Limited primary non-small cell lung cancers (NSCLC) (ie, graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0), or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases.
Up to 4 lesions may be considered.
For a single lesion, the sum of three orthogonal diameters can be no more than 20 cm.
For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm.
Both peripheral and central tumors are accepted for this trial.
Age ≥ 18 years old
Patients may be enrolled more than once (eg, for a new tumor lesion)

Reasons someone may not be able to joinExclusion criteria

Contraindication for radiotherapy
Pregnant and breastfeeding women are excluded
If prior radiation therapy, there is no overlap with the prior high dose regions (EXCEPTION: by approval of the investigators).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Stanford University Cancer InstituteStanford, California
Swedish Cancer InstituteSeattle, Washington
Princess Margaret Cancer CenterToronto, Ontario
Hokkaido University HospitalSapporo, Hokkaido

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2024. Always confirm current availability with the study team.

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