Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Not Applicable

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• 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; Radiation: iSABR, 60 Gray in 8 fractions for large central tumors

• Registration Number: NCT01463423
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-21
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-28
• Study First Posted: 2011-11-01
• Primary Completion: 2020-01-02
• Study Completion: 2022-02-07
• Results First Submitted: 2024-06-13
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Results First Posted: 2024-12-19
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Limited Primary Non-small Cell Lung Cancer (NSCLC)	iSABR, 50 Gray in 4 fractions for medium peripheral tumors	Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
History of NSCLC	iSABR, 25 Gray in 1 fraction for small peripheral tumors	Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
Advanced Lung Cancer Including Metastatic Lung Cancer	iSABR, 25 Gray in 1 fraction for small peripheral tumors	Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
Limited Primary Non-small Cell Lung Cancer (NSCLC)	iSABR, 25 Gray in 1 fraction for small peripheral tumors	Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
History of NSCLC	iSABR, 40 Gray in 4 fractions for small central tumors	Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
History of NSCLC	iSABR, 50 Gray in 4 fractions for medium central tumors	Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
Advanced Lung Cancer Including Metastatic Lung Cancer	iSABR, 50 Gray in 4 fractions for medium peripheral tumors	Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
Limited Primary Non-small Cell Lung Cancer (NSCLC)	iSABR, 54 Gray in 3 fractions for large peripheral tumors	Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
History of NSCLC	iSABR, 60 Gray in 8 fractions for large central tumors	Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
Advanced Lung Cancer Including Metastatic Lung Cancer	iSABR, 40 Gray in 4 fractions for small central tumors	Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
Advanced Lung Cancer Including Metastatic Lung Cancer	iSABR, 60 Gray in 8 fractions for large central tumors	Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
History of NSCLC	iSABR, 50 Gray in 4 fractions for medium peripheral tumors	Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
Advanced Lung Cancer Including Metastatic Lung Cancer	iSABR, 50 Gray in 4 fractions for medium central tumors	Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
History of NSCLC	iSABR, 54 Gray in 3 fractions for large peripheral tumors	Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
Limited Primary Non-small Cell Lung Cancer (NSCLC)	iSABR, 40 Gray in 4 fractions for small central tumors	Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
Limited Primary Non-small Cell Lung Cancer (NSCLC)	iSABR, 50 Gray in 4 fractions for medium central tumors	Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
Limited Primary Non-small Cell Lung Cancer (NSCLC)	iSABR, 60 Gray in 8 fractions for large central tumors	Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
Advanced Lung Cancer Including Metastatic Lung Cancer	iSABR, 54 Gray in 3 fractions for large peripheral tumors	Participants with more advanced lung cancer or lung metastases from a variety of different cancers.

Primary Outcome Measures

Name	Time	Method
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors	1 year	In concept, toxicity refers to adverse events caused by an intervention, ie, related adverse events. Toxicity will be assessed on the basis of related pulmonary; esophageal; chest wall; skin; vascular; cardiac/pericardial; and neurologic adverse events. Such events may have a number of different preferred terms for the adverse effect. The outcome will be reported as the number of Grade 3 or higher adverse effect events (toxicities), by Common Terminology Criteria for Adverse Events (CTCAE) Body System. The following exceptions apply.; * Gastrointestinal Disorders, Grade 4-5 only; * Atelectasis (collapse of the lung or lobe), Grade 4-5 only; * Grade 3 Hypoxia, only if worse than baseline All deaths related to treatment will be included. The outcome is numbers without dispersion.
Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors	up to 2 years	Radiotherapeutic dose levels to the tumor lesion may be limited by the proximity of critical organs. Reduced dose levels is believed to be associated with reduced therapeutic effect. This study will assess an anatomically-optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast radiotherapy delivery. Holding breath at a particular point in the breathing cycle may minimize proximity between tumor lesions and critical organs. In summary, participants will be coached to breath-hold at a certain point in their normal breathing cycle, and radiation will be quickly administered in bursts for several seconds. Up to 12 to 15 cycles of breath-hold may be needed to administer the desired dose level. Feasibility of this technique will be assessed as the number of patients able to reproduce the optimized breath-hold. The outcome is a number without dispersion.
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	Radiotherapeutic dose levels to the tumor lesion may be limited by the proximity of critical organs. Reduced dose levels is believed to be associated with reduced therapeutic effect. This study will assess an anatomically-optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast radiotherapy delivery. Holding breath at a particular point in the breathing cycle may minimize proximity between tumor lesions and critical organs. In summary, participants will be coached to breath-hold at a certain point in their normal breathing cycle, and radiation will be quickly administered in bursts for several seconds. Up to 12 to 15 cycles of breath-hold may be needed to administer the desired dose level. Utility of this technique will be assessed as the difference in treatment delivery time compared to free-breathing treatment, reported as the median with standard deviation.
Number of Participants With Progression-free Survival (PFS)	up to 2 years	Progression-free survival (PFS) is a measure of participant survival without disease recurrence, relapse, metastasis, or progression. The outcome is reported as the number of participants who were alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, and without disease progression during that time. The outcome is a number without dispersion.
Number of Participants With Metastasis-free Survival (MFS)	2 years	Metastasis refers to the ability of cancer cells to break free of a tumor, and migrate to another location in the body and start a new tumor lesion. Metastasis-free survival (MFS) is a measure of participant survival without disease metastasis. The outcome is reported as the number of participants who were alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, and without documented metastasis in that time. The outcome is a number without dispersion.
Number of Participants With Overall Survival (OS)	2 years	Overall survival (OS) is a measure of participant survival without regard to disease status. The outcome is reported as the number of participants who were documented as alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment. The outcome is a number without dispersion.

Trial Locations

Locations (4)

Stanford University Cancer Institute; 🇺🇸 Stanford, California, United States

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan