Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer

Conditions

• Early Stage Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Lymph Node Biopsy — PROCEDURE
  Undergo lymph node sampling
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan
• Stereotactic Body Radiation Therapy — RADIATION
  Receive SOC SBRT
• Stereotactic Body Radiation Therapy — RADIATION
  Receive hot spot SBRT
• Survey Administration — OTHER
  Ancillary studies

Study Details

This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer. SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment. This potentially may result in better control of the tumor, but also more side effects. SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.

Key Dates

First listed

Jul 22, 2026

Start date

Sep 1, 2026

Status verified

Jul 2026

Primary completion

Jun 25, 2029

Completion

Sep 1, 2029

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aim II (hot spot SBRT)
  Patients receive hot spot SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.
• Experimental: Arm I (SOC SBRT)
  Patients receive SOC SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.

Primary Outcome Measure

Time to progression (local control) [ Time Frame: Up to 2 years ]

Locations (1)

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