Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer
NCT00551369CI-TRIAL-00038385completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor. PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT
- description
- Stereotactic body radiation therapy (SBRT)
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- Primary Tumor Control at 2 Years
- timeFrame
- From start of treatment to 2 years.
- description
- Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types: * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Large cell neuroendocrine tumor * Non-small cell carcinoma not otherwise specified * No pure type bronchoalveolar cell carcinoma * Stage I or II disease based on 1 of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging: * T1, N0, M0 * T2 (≤ 5 cm), N0, M0 * T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only) * No T2 or T3 primary tumors \> 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum * No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi) * Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0 * Patients with \> 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer * No direct evidence of regional or distant metastases after appropriate staging studies * Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria: * Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon) * Baseline forced expiratory volume (FEV)\_1 \> 35% predicted * Postoperative predicted FEV\_1 \> 30% predicted * Diffusion capacity \> 35% predicted * No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) \> 50 mm Hg) at baseline * No severe pulmonary hypertension * No severe cerebral, cardiac, or peripheral vascular disease * No severe chronic heart disease * Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray * Pleural effusion that appears on chest x-ray will be allowed only after thoracotomy or other invasive procedure PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Absolute neutrophil count ≥ 1,800/mm³ * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusion allowed) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer * No active systemic, pulmonary, or pericardial infection * No weight loss \> 5% for any reason within the past 3 months PRIOR CONCURRENT THERAPY: * No prior radiotherapy for lung cancer * Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields * No prior chemotherapy or surgical resection for this lung cancer * No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, non-approved systemic therapy, and surgery), except at disease progression
References
Publications (1)
- DERIVEDTimmerman RD, Paulus R, Pass HI, Gore EM, Edelman MJ, Galvin J, Straube WL, Nedzi LA, McGarry RC, Robinson CG, Schiff PB, Chang G, Loo BW Jr, Bradley JD, Choy H. Stereotactic Body Radiation Therapy for Operable Early-Stage Lung Cancer: Findings From the NRG Oncology RTOG 0618 Trial. JAMA Oncol. 2018 Sep 1;4(9):1263-1266. doi: 10.1001/jamaoncol.2018.1251. PMID 29852037