Protocol for the Veterans Affairs Cooperative Studies Program Study Number 2005: A Phase 3 Randomized Trial of Lung...

Area of Science:

• Oncology
• Radiation Oncology
• Thoracic Surgery

Background:

• Standard care for stage I non-small cell lung cancer (NSCLC) includes surgery and stereotactic body radiation therapy (SBRT).
• Current guidelines recommend surgery for operable cases and SBRT for inoperable cases, despite limited evidence comparing long-term survival.
• A need exists to compare the efficacy of surgery versus SBRT in operable stage I NSCLC.

Purpose of the Study:

• To compare overall survival (OS) rates between surgery and SBRT in patients with operable stage I NSCLC.
• To evaluate secondary outcomes including quality of life, respiratory function, and patterns of lung cancer relapse.
• To provide evidence-based data for treatment decision-making in early-stage NSCLC.

Main Methods:

• Phase 3 randomized clinical trial comparing surgery and SBRT for stage I NSCLC (NCT02984761).
• Inclusion criteria: biopsy-confirmed NSCLC ≤ 5 cm, located > 1 cm from critical structures, and staged with PET scans and biopsies.
• Planned accrual of 670 patients to detect a 10% absolute benefit in 5-year OS.

Main Results:

• The study initiated in April 2017 and expanded to 16 sites in May 2019.
• As of July 5, 2023, 280 out of 670 planned participants have been enrolled.
• Recruitment interventions have helped overcome historical barriers to randomization between surgery and SBRT.

Conclusions:

• Final results are anticipated to clarify the role of SBRT versus surgery for operable stage I NSCLC.
• The study aims to facilitate informed patient-provider discussions regarding treatment options.
• Evidence from this trial will guide clinical practice and treatment guidelines for early-stage lung cancer.