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Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Not Recruiting
Trial ID: NCT01463423
Purpose
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.
Official Title
Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Stanford Investigator(s)
Maximilian Diehn, MD, PhD
Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)
Quynh-Thu Le, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Billy W Loo, Jr, MD PhD FASTRO FACR
Professor of Radiation Oncology (Radiation Therapy)
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).
Intervention(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
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Samantha Wong
650-498-8495