Clinical trial · Interventional
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iSABR, 25 Gray in 1 fraction for small peripheral tumors | Radiation | — | UNRESOLVED |
| iSABR, 40 Gray in 4 fractions for small central tumors | Radiation | — | UNRESOLVED |
| iSABR, 50 Gray in 4 fractions for medium central tumors | Radiation | — | UNRESOLVED |
| iSABR, 50 Gray in 4 fractions for medium peripheral tumors | Radiation | — | UNRESOLVED |
| iSABR, 54 Gray in 3 fractions for large peripheral tumors | Radiation | — | UNRESOLVED |
| iSABR, 60 Gray in 8 fractions for large central tumors | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Limited Primary Non-small Cell Lung Cancer (NSCLC)
- description
- Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
- interventionNames
- 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
- type
- EXPERIMENTAL
- label
- History of NSCLC
- description
- Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
- interventionNames
- Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDGensheimer MF, Gee H, Shirato H, Taguchi H, Snyder JM, Chin AL, Vitzthum LK, Maxim PG, Wakelee HA, Neal J, Das M, Chang DT, Kidd E, Hancock SL, Shultz DB, Horst KC, Le QT, Wong S, Brown E, Nguyen N, Liang R, Loo BW Jr, Diehn M. Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2023 Nov 1;9(11):1525-1534. doi: 10.1001/jamaoncol.2023.3495. PMID 37707820