Clinical trial · Interventional
Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways
Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways
NCT01051037CI-TRIAL-00038468completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency Ablation | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.
- interventionNames
- Radiation: Stereotactic Body Radiation
- Radiation: Radiofrequency Ablation
Primary outcomes (1)
- measure
- Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA.
- timeFrame
- 3 years
Secondary outcomes (6)
- measure
- Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy * Tumors \< 2 cm from trachea or zone of proximal bronchial tree (central tumors) * Each tumor \< 5 cm in size prior to treatment * Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery * Criterion for medical inoperability include: * Overall clinical assessment at the UCLA thoracic tumor board * Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: * Modified ACOSOG Criteria for medical inoperability: * Major Criteria: FEV1% \< 50% or \< 1L and DLCO \< 50% * Minor Criteria: Age \> 75, FEV1 51-60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF \< 40% or less), resting or exercise arterial pO2 \< 55 mmHg, and pCO2 \> 45 mmHg * Age \> 18 years old * KPS \> 70 * If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented. * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Prior thoracic radiation near the targets of interest * More than 2 central tumor targets per patient * Active infections requiring systemic antibiotics
References
Publications (0)
Data not yet available
No reference posted for this study.