N/A
N=256
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Non-small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT01463423 ↗Enrolled (actual)
256
Serious AEs
3.1%
Results posted
Dec 2024
Primary outcome: Primary: Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. — 34; 70; 60; 15 lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. |
34; 70; 60; 15; 6; 7 | — |
| SECONDARY Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors |
19; 31; 18; 8; 6; 3 | — |
| SECONDARY Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors |
— | — |
| SECONDARY Number of Participants With a Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) |
— | — |
| SECONDARY Number of Participants With Progression-free Survival (PFS) |
23; 26; 14; 9; 3; 3 | — |
| SECONDARY Number of Participants With Metastasis-free Survival (MFS) |
23; 26; 14; 9; 3; 3 | — |
| SECONDARY Number of Participants With Overall Survival (OS) |
28; 38; 34; 13; 4; 6 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT01463423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.