Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

NCT01463423 | Completed Results DMC FDA Device

• 3 other identifiers: IRB-22600SU-10202011-8537LUN0048
• Study Type: interventional
• Target: 256
• Locations: 3 countries
• Sites: 4

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.

  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.

  1 year

Secondary Outcomes (6)

• Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors

  1 year

• Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors

  up to 2 years

• Number of Participants With a Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR)

  up to 2 years

• Number of Participants With Progression-free Survival (PFS)

  up to 2 years

• Number of Participants With Metastasis-free Survival (MFS)

  2 years

Study Arms (3)

Limited Primary Non-small Cell Lung Cancer (NSCLC)

EXPERIMENTAL

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

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

History of NSCLC

EXPERIMENTAL

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

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

Advanced Lung Cancer Including Metastatic Lung Cancer

EXPERIMENTAL

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

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

Interventions

iSABR, 25 Gray in 1 fraction for small peripheral tumors RADIATION

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

Also known as: Individualized Stereotactic Ablative Radiotherapy (iSABR)

Advanced Lung Cancer Including Metastatic Lung Cancer; History of NSCLC; Limited Primary Non-small Cell Lung Cancer (NSCLC)

iSABR, 50 Gray in 4 fractions for medium peripheral tumors RADIATION

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

Also known as: Individualized Stereotactic Ablative Radiotherapy (iSABR)

Advanced Lung Cancer Including Metastatic Lung Cancer; History of NSCLC; Limited Primary Non-small Cell Lung Cancer (NSCLC)

iSABR, 54 Gray in 3 fractions for large peripheral tumors RADIATION

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

Also known as: Individualized Stereotactic Ablative Radiotherapy (iSABR)

Advanced Lung Cancer Including Metastatic Lung Cancer; History of NSCLC; Limited Primary Non-small Cell Lung Cancer (NSCLC)

iSABR, 40 Gray in 4 fractions for small central tumors RADIATION

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

Also known as: Individualized Stereotactic Ablative Radiotherapy (iSABR)

Advanced Lung Cancer Including Metastatic Lung Cancer; History of NSCLC; Limited Primary Non-small Cell Lung Cancer (NSCLC)

iSABR, 50 Gray in 4 fractions for medium central tumors RADIATION

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

Also known as: Individualized Stereotactic Ablative Radiotherapy (iSABR)

Advanced Lung Cancer Including Metastatic Lung Cancer; History of NSCLC; Limited Primary Non-small Cell Lung Cancer (NSCLC)

iSABR, 60 Gray in 8 fractions for large central tumors RADIATION

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

Also known as: Individualized Stereotactic Ablative Radiotherapy (iSABR)

Advanced Lung Cancer Including Metastatic Lung Cancer; History of NSCLC; Limited Primary Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (4)

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Princess Margaret Cancer Center

Toronto, Ontario, ON M5G 2M9, Canada

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Related Publications (1)

• 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.

  PMID: 37707820 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Maximilian Diehn, MD, PhD
• Organization: Stanford University

diehn@stanford.edu

650-725-4783

Study Officials

• Maximilian Diehn, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Bill Loo, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology (Radiation Therapy)

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: November 1, 2011
• Study Start: October 21, 2011
• Primary Completion: January 2, 2020
• Study Completion: February 7, 2022
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); JP (1); CA (1)