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

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

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, as will outcomes data.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer; Non-small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Estimated): 440

Contacts and Locations

• Study Contact: Name: Benjamin D Kozower, M.D., MPH; Phone Number: 314-362-8089; Email: kozowerb@wustl.edu

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • University of Toronto
      • Contact: Thomas Waddell, M.D., Ph.D.; Phone Number: 416-978-2011
      • Principal Investigator: Thomas Waddell, M.D., Ph.D.
      • Sub-Investigator: Alexander Sun, M.D.
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Felix Fernandez, M.D.; Phone Number: 404-778-7777
      • Principal Investigator: Felix Fernandez, M.D.
      • Sub-Investigator: Kristin Higgins, M.D.
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • Carle Cancer Institute
      • Contact: Sinisa Stanic, M.D.; Phone Number: 217-383-3311
      • Principal Investigator: Sinisa Stanic, M.D.
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Benjamin D Kozower, M.D., MPH; Phone Number: 314-362-8089; Email: kozowerb@wustl.edu
      • Principal Investigator: Benjamin D Kozower, M.D., MPH
      • Sub-Investigator: Varun Puri, M.D., MSCI
      • Sub-Investigator: Margaret Olsen, Ph.D., MPH
      • Sub-Investigator: Esther Lu, Ph.D.
      • Sub-Investigator: Cliff Robinson, M.D.
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering
      • Contact: David Jones, M.D.; Phone Number: 212-639-2000
      • Principal Investigator: David Jones, M.D.
      • Sub-Investigator: Narek Shaverdian, M.D.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: David Harpole, M.D.; Phone Number: 919-668-8413
      • Principal Investigator: David Harpole, M.D.
      • Sub-Investigator: Joseph Salama, M.D.
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Alejandro Bribriesco, M.D.; Phone Number: 216-445-8140
      • Principal Investigator: Alejandro Bribriesco, M.D.
      • Sub-Investigator: Kevin Stephens, M.D.
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
      • Contact: Ara Vaporciyan, M.D.; Phone Number: 877-284-1820
      • Principal Investigator: Ara Vaporciyan, M.D.
      • Sub-Investigator: Joe Chang, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who meet the eligibility criteria from any of the participating sites listed.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Surgery; Participants will have standard of care lobectomy/segmentectomy/wedge resection. Decision for treatment will be made at the discretion of the treating physician.; PROMIS instruments include 8 domains and will be completed prior to treatment, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatmentBank 2.0 - Physical FunctionBank v1.1 - Pain InterferenceBank v1.0 - FatigueBank v1.0 - DepressionBank v1.0 - AnxietyBank v1.0 - Dyspnea SeverityBank v2.0 - Ability to Participate in Social Roles and ActivitiesBank v2.0 - Cognitive Function
Stereotactic body radiotherapy (SBRT); Participants will have standard of care 1-10 fractions of radiation therapy. Decision for treatment will be made at the discretion of the treating physician.; PROMIS instruments include 8 domains and will be completed prior to treatment, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatmentBank v2.0 - Physical FunctionBank v1.1 - Pain InterferenceBank v1.0 - FatigueBank v1.0 - DepressionBank v1.0 - AnxietyBank v1.0 - Dyspnea SeverityBank v2.0 - Ability to Participate in Social Roles and ActivitiesBank v2.0 - Cognitive Function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival (DFS)	DFS is defined as time from the date of treatment to date of disease recurrence or death, whichever occurs earlier.	Through 36 months post-treatment (estimated to be 36 months and 1 week)
Change in patient-reported outcomes as measured by the PROMIS Bank survey	Surveys will occur at baseline, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment; The PROMIS scores will be compared across the 8 pre-specified domains:Cancer Bank v1.1 - Physical FunctionCancer Bank v1.1 - Pain InterferenceCancer Bank v1.0 - FatigueCancer Bank v1.0 - DepressionCancer Bank v1.0 - AnxietyBank v1.0 - Dyspnea SeverityBank v2.0 - Ability to Participate in Social Roles and ActivitiesBank v2.0 - Cognitive Function; PROMIS is scored 1-100 and normalizes to the population mean of 50 with each 10 being a standard deviation. A higher score indicates a worse patient-reported outcome.	From baseline through 36 months post-treatment (estimated to be 36 months and 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer-specific survival (CSS)	Cancer-specific survival (CSS) is defined as time from the date of treatment to date of cancer-related death. The alive patients without any signs or symptoms of that cancer are censored at the last follow-up.	Through 36 months post-treatment (estimated to be 36 months and 1 week)
Overall survival (OS)	Overall survival (OS) is defined as time from the date of treatment to date of death. The alive patients are censored at the last follow-up.	Through 36 months post-treatment (estimated to be 36 months and 1 week)
Treated-related mortality		At 30 days (estimated to be 1 month and 1 week)
Number of post-treatment events (grade 3 and above)	Post-treatment grade 3-5 events measured via CTCAE version 5.0	Through 36 months post-treatment (estimated to be 36 months and 1 week)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Benjamin D Kozower, M.D., MPH, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 202112102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No