Back to resultsIndividualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Primary Purpose
Non-small Cell Lung Cancer (NSCLC)
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
iSABR, 25 Gray in 1 fraction for small peripheral tumors
iSABR, 50 Gray in 4 fractions for medium peripheral tumors
iSABR, 54 Gray in 3 fractions for large peripheral tumors
iSABR, 40 Gray in 4 fractions for small central tumors
iSABR, 50 Gray in 4 fractions for medium central tumors
iSABR, 60 Gray in 8 fractions for large central tumors
Sponsored by
About this trial
This is an interventional health services research trial for Non-small Cell Lung Cancer (NSCLC)
Eligibility Criteria
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).
Sites / Locations
- Stanford University Cancer Institute
- Swedish Cancer Institute
- Princess Margaret Cancer Center
- Hokkaido University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Limited Primary Non-small Cell Lung Cancer (NSCLC)
History of NSCLC
Advanced Lung Cancer Including Metastatic Lung Cancer
Arm Description
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
Outcomes
Primary Outcome Measures
Evaluate Local Tumor Control with Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for lung tumors.
Tumor control will be assessed by CT, PET-CT, and if appropriate, biopsy. Tumor control is defined as a determination that the participant has not experienced Local Failure at the treatment lesion, meaning primary tumor failure or involved lobe failure or both. The outcome is reported as the number of participants who maintain tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, a number without dispersion.
Secondary Outcome Measures
Toxicity of Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
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.
Feasibility of Using an Optimized Breath-hold Technique during Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors
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.
Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique
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.
Progression-free survival (PFS)
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.
Metastasis-free Survival (MFS)
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.
Overall Survival (OS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01463423
Brief Title
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Official Title
Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2011 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
February 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Limited Primary Non-small Cell Lung Cancer (NSCLC)
Arm Type
Experimental
Arm Description
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
Arm Title
History of NSCLC
Arm Type
Experimental
Arm Description
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
Arm Title
Advanced Lung Cancer Including Metastatic Lung Cancer
Arm Type
Experimental
Arm Description
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
Intervention Type
Radiation
Intervention Name(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors
Other Intervention Name(s)
Individualized Stereotactic Ablative Radiotherapy (iSABR)
Intervention Description
Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
Intervention Type
Radiation
Intervention Name(s)
iSABR, 50 Gray in 4 fractions for medium peripheral tumors
Other Intervention Name(s)
Individualized Stereotactic Ablative Radiotherapy (iSABR)
Intervention Description
Radiotherapy procedure for participants with medium peripheral tumors > 10 cc and ≤ 30 cc.
Intervention Type
Radiation
Intervention Name(s)
iSABR, 54 Gray in 3 fractions for large peripheral tumors
Other Intervention Name(s)
Individualized Stereotactic Ablative Radiotherapy (iSABR)
Intervention Description
Radiotherapy procedure for participants with large peripheral tumors > 30 cc.
Intervention Type
Radiation
Intervention Name(s)
iSABR, 40 Gray in 4 fractions for small central tumors
Other Intervention Name(s)
Individualized Stereotactic Ablative Radiotherapy (iSABR)
Intervention Description
Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
Intervention Type
Radiation
Intervention Name(s)
iSABR, 50 Gray in 4 fractions for medium central tumors
Other Intervention Name(s)
Individualized Stereotactic Ablative Radiotherapy (iSABR)
Intervention Description
Radiotherapy procedure for participants with medium central tumors > 10 cc and ≤ 30 cc.
Intervention Type
Radiation
Intervention Name(s)
iSABR, 60 Gray in 8 fractions for large central tumors
Other Intervention Name(s)
Individualized Stereotactic Ablative Radiotherapy (iSABR)
Intervention Description
Radiotherapy procedure for participants with large central tumors > 30 cc.
Primary Outcome Measure Information:
Title
Evaluate Local Tumor Control with Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for lung tumors.
Description
Tumor control will be assessed by CT, PET-CT, and if appropriate, biopsy. Tumor control is defined as a determination that the participant has not experienced Local Failure at the treatment lesion, meaning primary tumor failure or involved lobe failure or both. The outcome is reported as the number of participants who maintain tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, a number without dispersion.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Toxicity of Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
Description
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.
Time Frame
1 year
Title
Feasibility of Using an Optimized Breath-hold Technique during Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors
Description
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.
Time Frame
up to 2 years
Title
Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique
Description
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.
Time Frame
up to 2 years
Title
Progression-free survival (PFS)
Description
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.
Time Frame
up to 2 years
Title
Metastasis-free Survival (MFS)
Description
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.
Time Frame
2 years
Title
Overall Survival (OS)
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maximilian Diehn, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bill Loo, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
ON M5G 2M9
Country
Canada
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
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