MedDataX Logo

Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

NCT ID: NCT01463423

Last Updated: 2024-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-21

Study Completion Date

2022-02-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer (NSCLC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Limited Primary Non-small Cell Lung Cancer (NSCLC)

Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)

Group Type EXPERIMENTAL

iSABR, 25 Gray in 1 fraction for small peripheral tumors

Intervention Type RADIATION

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

iSABR, 50 Gray in 4 fractions for medium peripheral tumors

Intervention Type RADIATION

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

iSABR, 54 Gray in 3 fractions for large peripheral tumors

Intervention Type RADIATION

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

iSABR, 40 Gray in 4 fractions for small central tumors

Intervention Type RADIATION

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

iSABR, 50 Gray in 4 fractions for medium central tumors

Intervention Type RADIATION

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

iSABR, 60 Gray in 8 fractions for large central tumors

Intervention Type RADIATION

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

History of NSCLC

Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)

Group Type EXPERIMENTAL

iSABR, 25 Gray in 1 fraction for small peripheral tumors

Intervention Type RADIATION

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

iSABR, 50 Gray in 4 fractions for medium peripheral tumors

Intervention Type RADIATION

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

iSABR, 54 Gray in 3 fractions for large peripheral tumors

Intervention Type RADIATION

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

iSABR, 40 Gray in 4 fractions for small central tumors

Intervention Type RADIATION

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

iSABR, 50 Gray in 4 fractions for medium central tumors

Intervention Type RADIATION

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

iSABR, 60 Gray in 8 fractions for large central tumors

Intervention Type RADIATION

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

Advanced Lung Cancer Including Metastatic Lung Cancer

Participants with more advanced lung cancer or lung metastases from a variety of different cancers.

Group Type EXPERIMENTAL

iSABR, 25 Gray in 1 fraction for small peripheral tumors

Intervention Type RADIATION

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

iSABR, 50 Gray in 4 fractions for medium peripheral tumors

Intervention Type RADIATION

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

iSABR, 54 Gray in 3 fractions for large peripheral tumors

Intervention Type RADIATION

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

iSABR, 40 Gray in 4 fractions for small central tumors

Intervention Type RADIATION

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

iSABR, 50 Gray in 4 fractions for medium central tumors

Intervention Type RADIATION

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

iSABR, 60 Gray in 8 fractions for large central tumors

Intervention Type RADIATION

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iSABR, 25 Gray in 1 fraction for small peripheral tumors

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

Intervention Type RADIATION

iSABR, 50 Gray in 4 fractions for medium peripheral tumors

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

Intervention Type RADIATION

iSABR, 54 Gray in 3 fractions for large peripheral tumors

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

Intervention Type RADIATION

iSABR, 40 Gray in 4 fractions for small central tumors

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

Intervention Type RADIATION

iSABR, 50 Gray in 4 fractions for medium central tumors

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

Intervention Type RADIATION

iSABR, 60 Gray in 8 fractions for large central tumors

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

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Individualized Stereotactic Ablative Radiotherapy (iSABR) Individualized Stereotactic Ablative Radiotherapy (iSABR) Individualized Stereotactic Ablative Radiotherapy (iSABR) Individualized Stereotactic Ablative Radiotherapy (iSABR) Individualized Stereotactic Ablative Radiotherapy (iSABR) Individualized Stereotactic Ablative Radiotherapy (iSABR)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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)

Exclusion 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maximilian Diehn

Professor of Radiation Oncology (Radiation Therapy)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maximilian Diehn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Bill Loo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University Cancer Institute

Stanford, California, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Japan

References

Explore related publications, articles, or registry entries linked to this study.

Gensheimer MF, Gee H, Shirato H, Taguchi H, Snyder JM, Chin AL, Vitzthum LK, Maxim PG, Wakelee HA, Neal J, Das M, Chang DT, Kidd E, Hancock SL, Shultz DB, Horst KC, Le QT, Wong S, Brown E, Nguyen N, Liang R, Loo BW Jr, Diehn M. Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2023 Nov 1;9(11):1525-1534. doi: 10.1001/jamaoncol.2023.3495.

Reference Type DERIVED
PMID: 37707820 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SU-10202011-8537

Identifier Type: OTHER

Identifier Source: secondary_id

LUN0048

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-22600

Identifier Type: -

Identifier Source: org_study_id