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Official Title

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

Sponsor
Washington University School of Medicine
Enrollment
444
Timeline
Jul 2022 → Jan 2029
About This Study

The development of stereotactic body radiation therapy (SBRT) for the treatment of stage I non-small cell lung cancer (NSCLC) has inspired a close partnership between thoracic surgery and radiation oncology. In this study, patients with stage I NSCLC will be screened prior to treatment and will be consented after their treatment plan has been determined. Prospectively collected patient-reported outcomes (PROs) will be collected for 3 years or for the duration of the study (whichever is shorter), as will outcomes data.

Eligibility Criteria

Inclusion Criteria

  • 1Clinical stage I NSCLC (T1 or T2a, N0, M0) by CT performed within 90 days of screening.
  • 2PET/CT is required within 90 days of screening except under circumstances where the clinical picture suggests, or biopsy confirms, a low-grade adenocarcinoma.
  • 3Biopsy is strongly encouraged. In the event biopsy is not performed, rationale must be provided for performing empiric treatment.
  • 4Patients 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.
  • 5First primary NSCLC on the ipsilateral side.
  • 6At least 18 years of age.
  • 7Clinically 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:
  • 8ECOG performance status ≤ 2
  • 9No home oxygen use
  • 10FEV1 and DLCO ≥ 40% predicted
  • 11No symptomatic congestive heart failure as documented by NYHA I-II functional classification
  • 12Been 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.
  • 13Been 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.
  • 14Ability to understand and willingness to sign an IRB-approved written informed consent document.
  • 15Agrees to receive treatment for clinical stage I NSCLC (either surgical resection or SBRT).

Exclusion Criteria

  • 1Prior 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.
  • 2Clinically diagnosed or biopsy proven low-grade neuroendocrine carcinoma (carcinoid).
  • 3Prior thoracic radiation therapy that would overlap with the lung cancer being treated on study.
  • 4Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on study.
  • 5Prior lung resection on the ipsilateral side positive for malignancy.
  • 6Patients with central tumors requiring a sleeve lobectomy or pneumonectomy.
  • 7"Ultra-central" lesions (defined as a lesion that directly contacts or overlaps the trachea, main bronchus, esophagus, or pulmonary vessels).
  • 8Concurrent enrollment in a therapeutic trial for the index cancer.
  • 9Synchronous primary lung cancer.
  • 10Uncontrolled or symptomatic psychiatric condition.

Locations

8 sites participating in this study

Emory University

Atlanta, Georgia 30322

Active, Not Recruiting

Carle Cancer Institute

Urbana, Illinois 61801

Recruiting

Sinisa Stanic, M.D.

Washington University School of Medicine

St Louis, Missouri 63110

Recruiting

Benjamin D Kozower, M.D., MPH

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →