Gene Therapy Clinical Trials
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
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
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).
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Samantha Wong
650-498-8495
Not Recruiting