Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer

Running, not enrolling · Phase 1

Conditions studied: Lung Non-Small Cell Carcinoma, Positive Surgical Margin, Resected Mass, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT04073745

Run by

Roswell Park Cancer Institute

People needed

50

Starts

2019-12-04

Expected to finish

2026-07-31

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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