Clinical trial · Interventional
Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer
Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer
NCT03348748CI-TRIAL-00107136terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Non-Small Cell Lung Carcinoma AJCC v7 | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IB Non-Small Cell Lung Carcinoma AJCC v7 | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Non-Small Cell Lung Cancer AJCC v7 | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Drug | — | UNRESOLVED |
| Thoracic Surgical Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Study 1 (highest-dose of SBRT, surgery)
- description
- Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Drug: Stereotactic Body Radiation Therapy
- Procedure: Thoracic Surgical Procedure
- type
- EXPERIMENTAL
- label
- Study 2 (lowest-dose of SBRT, surgery)
- description
- Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa) * Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed * Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for \>3 years * Participant is able to undergo surgery (planned lobectomy or wedge resection) * Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Contraindication to SBRT (this includes the inability to cooperate with any aspect of SBRT: such as the inability to lie still and breathe reproducibly) * Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor * Previous surgery for this lung or mediastinum tumor * Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression * Patients with active systemic, pulmonary, or pericardial infection * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the investigator?s opinion deems the participant ineligible * Received an investigational agent within 30 days prior to enrollment * Stage IIIb
References
Publications (0)
Data not yet available
No reference posted for this study.