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

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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 or for the duration of the study (whichever is shorter), as will outcomes data.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Carle Cancer Institute
RECRUITING
Urbana
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
New York
Memorial Sloan Kettering
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Canada
University of Toronto
RECRUITING
Toronto
Contact Information
Primary
Benjamin D Kozower, M.D., MPH
kozowerb@wustl.edu
314-362-8089
Time Frame
Start Date: 2022-07-14
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 444
Treatments
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
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-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
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov