Comparing surgery and radiation therapy for early-stage lung cancer

Comparing the Effectiveness of Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer (SORT)

This study is testing whether surgery or a type of radiation therapy works better for people with early-stage lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 440 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 8 sites (Atlanta, Georgia and 7 other locations)
• Trial ID: NCT05183932 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of surgery versus stereotactic body radiation therapy (SBRT) for patients with stage I non-small cell lung cancer (NSCLC). Patients will be screened and consented after their treatment plan is established, and their outcomes will be monitored over three years. The study aims to collect patient-reported outcomes and other relevant data to assess the benefits and drawbacks of each treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with clinically staged I NSCLC who are eligible for either surgical resection or SBRT.

Not a fit: Patients with advanced lung cancer or those who do not meet the eligibility criteria for stage I NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the most effective treatment options for early-stage lung cancer patients.

How similar studies have performed: Previous studies have shown promising results in comparing surgical and radiation approaches for lung cancer, indicating that this research builds on established findings.

Eligibility criteria

Inclusion Criteria:

* Clinical stage I NSCLC (T1 or T2a, N0, M0) by CT performed within 90 days of screening.

  * PET/CT is required within 90 days of screening except under circumstances where the clinical picture suggests, or biopsy confirms, a low-grade adenocarcinoma.
  * Biopsy is strongly encouraged. In the event biopsy is not performed, rationale must be provided for performing empiric treatment.
  * Patients with hilar or mediastinal lymph nodes ≤ 1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Pre-treatment mediastinal lymph node sampling by any technique is allowed but not required. Patients with \> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) are be eligible only if directed tissue biopsies of all abnormally identified areas are negative for cancer.
* First primary NSCLC on the ipsilateral side.
* At least 18 years of age.
* Clinically eligible for either treatment (surgical resection or SBRT). Because this is a pragmatic study and treatment decisions are at the discretion of the treating physicians and their patients, patients must be eligible for either treatment. To be considered eligible for either treatment, patients must have:

  * ECOG performance status ≤ 2
  * No home oxygen use
  * FEV1 and DLCO ≥ 40% predicted
  * No symptomatic congestive heart failure as documented by NYHA I-II functional classification
  * Been deemed operable by a thoracic surgeon, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to operability, the surgeon must define what anticipated surgical approach and procedure would be undertaken.
  * Been deemed treatable by a radiation oncologist with 10 or fewer fractions of SBRT, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to suitability for SBRT, the radiation oncologist must define which dose and fractionation would be undertaken.
* Ability to understand and willingness to sign an IRB-approved written informed consent document.
* Agrees to receive treatment for clinical stage I NSCLC (either surgical resection or SBRT).

Exclusion Criteria:

* Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study.
* Clinically diagnosed or biopsy proven low-grade neuroendocrine carcinoma (carcinoid).
* Prior thoracic radiation therapy that would overlap with the lung cancer being treated on study.
* Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on study.
* Prior lung resection on the ipsilateral side positive for malignancy.
* Patients with central tumors requiring a sleeve lobectomy or pneumonectomy.
* "Ultra-central" lesions (defined as a lesion that directly contacts or overlaps the trachea, main bronchus, esophagus, or pulmonary vessels).
* Concurrent enrollment in a therapeutic trial for the index cancer.
* Synchronous primary lung cancer.
* Uncontrolled or symptomatic psychiatric condition.

Where this trial is running

Atlanta, Georgia and 7 other locations

• Emory University — Atlanta, Georgia, United States (Recruiting)
• Carle Cancer Institute — Urbana, Illinois, United States (Recruiting)
• Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
• Memorial Sloan Kettering — New York, New York, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• University of Toronto — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Benjamin D Kozower, M.D., MPH — Washington University School of Medicine
• Study coordinator: Benjamin D Kozower, M.D., MPH

Conditions Non Small Cell Lung Cancer; Non-small Cell Lung Cancer