Clinical trial NCT05183932: Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer
Official title: Comparing the Effectiveness of Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer (SORT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Non-small Cell Lung Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-01-11
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who meet the eligibility criteria from any of the participating sites listed.

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.


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.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
measure: Change in patient-reported outcomes as measured by the PROMIS Bank survey
timeFrame: From baseline through 36 months post-treatment (estimated to be 36 months and 1 week)
Secondary outcomes:
measure: Cancer-specific survival (CSS)
timeFrame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
measure: Overall survival (OS)
timeFrame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
measure: Treated-related mortality
timeFrame: At 30 days (estimated to be 1 month and 1 week)
measure: Number of post-treatment events (grade 3 and above)
timeFrame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Urbana
country: United States
facility: Carle Cancer Institute
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: Washington University School of Medicine
name: Benjamin D Kozower, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: