SORT: Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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-treatment Bank 2.0 - Physical Function Bank v1.1 - Pain Interference Bank v1.0 - Fatigue Bank v1.0 - Depression Bank v1.0 - Anxiety Bank v1.0 - Dyspnea Severity Bank v2.0 - Ability to Participate in Social Roles and Activities Bank v2.0 - Cognitive Function |
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| Stereotactic body radiotherapy (SBRT) Participants will have standard of care 1-5 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-treatment Bank v2.0 - Physical Function Bank v1.1 - Pain Interference Bank v1.0 - Fatigue Bank v1.0 - Depression Bank v1.0 - Anxiety Bank v1.0 - Dyspnea Severity Bank v2.0 - Ability to Participate in Social Roles and Activities Bank v2.0 - Cognitive Function |
Outcome Measures
Primary Outcome Measures
- Disease-free survival (DFS) [Through 36 months post-treatment (estimated to be 36 months and 1 week)]
DFS is defined as time from the date of treatment to date of disease recurrence or death, whichever occurs earlier.
- Change in patient-reported outcomes as measured by the PROMIS Bank survey [From baseline through 36 months post-treatment (estimated to be 36 months and 1 week)]
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 Function Cancer Bank v1.1 - Pain Interference Cancer Bank v1.0 - Fatigue Cancer Bank v1.0 - Depression Cancer Bank v1.0 - Anxiety Bank v1.0 - Dyspnea Severity Bank v2.0 - Ability to Participate in Social Roles and Activities Bank 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.
Secondary Outcome Measures
- Cancer-specific survival (CSS) [Through 36 months post-treatment (estimated to be 36 months and 1 week)]
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.
- Overall survival (OS) [Through 36 months post-treatment (estimated to be 36 months and 1 week)]
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.
- Treated-related mortality [At 30 days (estimated to be 1 month and 1 week)]
- Number of post-treatment events (grade 3 and above) [Through 36 months post-treatment (estimated to be 36 months and 1 week)]
Post-treatment grade 3-5 events measured via CTCAE version 5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical stage I NSCLC (T1 or T2a, N0, M0) by integrated PET/CT scan performed within 90 days of screening. 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) may still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer.
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First primary NSCLC on the ipsilateral side.
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At least 18 years of age.
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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. In order to be considered eligible for either treatment, patients must have:
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ECOG performance status ≤ 2
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No home oxygen use
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FEV1 and DLCO ≥ 40% predicted
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No symptomatic congestive heart failure as documented by NYHA I-II functional classification
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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.
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Been deemed treatable by a radiation oncologist with 5 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.
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Ability to understand and willingness to sign an IRB-approved written informed consent document.
Exclusion Criteria:
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A history of other invasive malignancy with the exception of malignancies for which all treatment was completed at least 3 years before registration and the patient has no evidence of active disease.
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Suspicious or biopsy proven low-grade neuroendocrine carcinoma (carcinoid).
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Received prior intra-thoracic radiation therapy that would overlap with the current lung cancer.
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Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated.
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Prior lung resection on the ipsilateral side.
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Patients with central tumors requiring a sleeve lobectomy or pneumonectomy.
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"Ultra-central" lesions (defined as a lesion that directly contacts or overlaps the trachea, main bronchus, esophagus, or pulmonary vessels), or those for which a more extended fractionation would be required to safely treat with SBRT.
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Concurrent enrollment in a therapeutic trial for the index cancer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University | Atlanta | Georgia | United States | 30322 |
| 2 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 3 | Memorial Sloan Kettering | New York | New York | United States | 10065 |
| 4 | Duke University | Durham | North Carolina | United States | 27710 |
| 5 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 6 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 7 | University of Toronto | Toronto | Ontario | Canada |
Sponsors and Collaborators
- Washington University School of Medicine
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Benjamin D Kozower, M.D., MPH, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 202112102