Clinical trial · Interventional
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
- 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)
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
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 |
|---|---|---|---|
| Arm 1 stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
| Arm II stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
- interventionNames
- Radiation: Arm 1 stereotactic body radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
- interventionNames
- Radiation: Arm II stereotactic body radiation therapy
Primary outcomes (3)
- measure
- Incidence of AE Grade 3 or Higher Toxicity
- timeFrame
- 1year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer * T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded) * Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection * Age \>= 18 Exclusion Criteria: * Prior thoracic radiation therapy * T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement * Node positive or metastatic disease * Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree. * No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly) * Pregnant or unwilling to use adequate contraception
References
Publications (0)
Data not yet available