Clinical trial · Interventional
Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Summary
Brief summary (as posted)
RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. 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 whether stereotactic body radiation therapy is more effective than surgery with or without internal radiation therapy in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well surgery with or without internal radiation therapy works compared with stereotactic body radiation therapy in treating patients with high-risk stage IA or stage IB 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iodine I 125 | Radiation | — | UNRESOLVED |
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (SR+Brachytherapy)
- description
- Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
- interventionNames
- Procedure: therapeutic conventional surgery
- Radiation: iodine I 125
- type
- EXPERIMENTAL
- label
- Arm II (SBRT)
- description
- Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.
- interventionNames
- Radiation: stereotactic body radiation therapy
Primary outcomes (1)
- measure
- 3-year Overall Survival (OS) Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Lung nodule suspicious for non-small cell lung cancer (NSCLC)
* Biopsy confirmation is strongly recommended but not required; if biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on two or more of the following criteria:
* Positive smoking history
* Absence of benign calcifications within suspicious nodule
* Activity on PET greater than normal tissue
* Evidence of growth compared to previous imaging
* Presence of spiculation
* Tumor ≤ 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration
* All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (\> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration, CT-guided, or video-assisted thoracoscopic or open lymph node biopsy
* Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection
* Tumor located peripherally within the lung, defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions
* Patients with non-peripheral (central) tumors are NOT eligible
* No evidence of distant metastases
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0, 1, or 2
* Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below:
* Major criteria
* FEV1 ≤ 50% predicted
* DLCO ≤ 50% predicted
* Minor criteria
* Age ≥ 75 years
* FEV1 51-60% predicted
* DLCO 51-60% predicted
* Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization
* Poor left ventricular function (defined as an ejection fraction of 40% or less)
* Resting or exercise arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%
* pCO2 \> 45 mm Hg
* Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3
* Not pregnant or nursing
* Negative urine or serum pregnancy test
* Fertile patients must use effective contraception
* No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (except non-melanoma skin cancer, in-situ cancers).
PRIOR CONCURRENT THERAPY:
* No prior intra-thoracic radiotherapy
* Prior radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted
* Prior chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permittedReferences
Publications (1)
- RESULTFernando HC, Timmerman R. American College of Surgeons Oncology Group Z4099/Radiation Therapy Oncology Group 1021: a randomized study of sublobar resection compared with stereotactic body radiotherapy for high-risk stage I non-small cell lung cancer. J Thorac Cardiovasc Surg. 2012 Sep;144(3):S35-8. doi: 10.1016/j.jtcvs.2012.06.003. Epub 2012 Jul 11. PMID 22795435