RECRUITING

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

Conditions

Non Small Cell Lung Cancer Non-small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-14

Study Completion:2029-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05183932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Benjamin D Kozower, M.D., MPH

CONTACT

314-362-8089

kozowerb@wustl.edu

Principal Investigator

Benjamin D Kozower, M.D., MPH

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30322

United States

Carle Cancer Institute

Urbana, Illinois, 61801

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Memorial Sloan Kettering

New York, New York, 10065

United States

Duke University

Durham, North Carolina, 27710

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Benjamin D Kozower, M.D., MPH, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-14

Study Completion Date2029-01-31

Study Record Updates

Study Start Date2022-07-14

Study Completion Date2029-01-31

Terms related to this study

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer
Non-small Cell Lung Cancer