Clinical trial · Interventional
Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative 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)
This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.
Conditions
Conditions (10)
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 Non-Small Cell Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
| Positive Surgical Margin | — | UNRESOLVED | — |
| Resected Mass | — | UNRESOLVED | — |
| Stage IIIA Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Lung Cancer AJCC v8 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT)
- description
- Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (2)
- measure
- Incidence of grade 3 or greater toxicities
- timeFrame
- Up to 5 years
- description
- Hospitalization resulting from radiation treatment will be recorded. Any acute (=\< 180 days after the end of radiation therapy \[RT\]) and late (\> 180 days after the end of RT) toxicities will be documented using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals (alpha = 0.10).
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 =\< 2 * Has completed curative-intent surgical resection of lung primary with pathologic diagnosis of NSCLC disease, with pathology to include at least 1 of the following: * Close (\<=2 mm) or Positive surgical margin (R1/R2) or pathologic N2 disease (with or without extracapsular extension \[ECE\]) * Anatomic pulmonary resection (lobectomy or pneumonectomy) preferred, although sublobar resection is allowed at the discretion of the treating surgeon. Systemic lobe-specific nodal sampling is required. A minimum of 3 N2 stations must be sampled. Selective lymph node dissection should be completed for patients with known N2 disease * Women of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) * Patient or legal representative must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments * Patient 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 breath reproducibly * Prior radiation therapy targeting the same area for which radiation treatment is being planned * Pregnant or nursing female patients * Unwilling or unable to follow protocol requirements * Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment * Patients who undergo sublobar resection but are unable to undergo appropriate N1 and N2 lymph node sampling
References
Publications (0)
Data not yet available