Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463423
• Other study ID #: IRB-22600
• Secondary ID: SU-10202011-8537
• Status: Completed
• Phase: N/A
• Start date: October 21, 2011
• Est. completion date: February 7, 2022

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: February 7, 2022
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Radiation:
• iSABR, 25 Gray in 1 fraction for small peripheral tumors
Radiotherapy procedure for participants with small peripheral tumors = 10 cc.
• iSABR, 50 Gray in 4 fractions for medium peripheral tumors
Radiotherapy procedure for participants with medium peripheral tumors > 10 cc and = 30 cc.
• iSABR, 54 Gray in 3 fractions for large peripheral tumors
Radiotherapy procedure for participants with large peripheral tumors > 30 cc.
• iSABR, 40 Gray in 4 fractions for small central tumors
Radiotherapy procedure for participants with small central tumors = 10 cc.
• iSABR, 50 Gray in 4 fractions for medium central tumors
Radiotherapy procedure for participants with medium central tumors > 10 cc and = 30 cc.
• iSABR, 60 Gray in 8 fractions for large central tumors
Radiotherapy procedure for participants with large central tumors > 30 cc.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
United States	Swedish Cancer Institute	Seattle	Washington
United States	Stanford University Cancer Institute	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	up to 2 years
Secondary	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.	up to 2 years
Secondary	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.	up to 2 years
Secondary	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.	2 years
Secondary	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.	2 years