Clinical trial · Interventional
Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer
Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue. In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT with proton beam radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT with proton beam radiation
- description
- 4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of \> 3 cm)
- interventionNames
- Radiation: SBRT with proton beam radiation
Primary outcomes (2)
- measure
- Feasibility and safety
- timeFrame
- 2 years
- description
- To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)
- measure
- Safety and tolerability
- timeFrame
- 2 years
- description
- Frequency of radiation pneumonitis in participants treated with proton radiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed) * Stage clinical T1 N0 M0 or T2 N0 M0 * NSCLC must be limited to a single lesion * NSCLC must be peripherally located (\> 2 cm from proximal bronchial tree and \> 1 cm from mediastinal pleura) * NSCLC must be considered medically inoperable * Life expectancy greater than 6 months Exclusion Criteria: * Pregnant or breastfeeding * Prior radiation therapy to the lungs or mediastinum * Prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated * Receiving other study agents or other types of cancer therapy * Uncontrolled intercurrent illness * Pacemaker or defibrillator-dependent
References
Publications (0)
Data not yet available