Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.
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. In order 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 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.
Ability to understand and willingness to sign an IRB-approved written informed consent document.

Exclusion Criteria:

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.
Suspicious or biopsy proven low-grade neuroendocrine carcinoma (carcinoid).
Received prior intra-thoracic radiation therapy that would overlap with the current lung cancer.
Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated.
Prior lung resection on the ipsilateral side.
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), or those for which a more extended fractionation would be required to safely treat with SBRT.
Concurrent enrollment in a therapeutic trial for the index cancer.

Study is for people with:

Lung Cancer

Estimated Enrollment:

438

Study ID:

NCT05183932

Recruitment Status:

Recruiting

Sponsor:

Washington University School of Medicine

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There are 6 Locations for this study

See Locations Near You

Emory University
Atlanta Georgia, 30322, United States More Info
Felix Fernandez, M.D.
Contact
404-778-7777
Felix Fernandez, M.D.
Principal Investigator
Kristin Higgins, M.D.
Sub-Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Benjamin D Kozower, M.D., MPH
Contact
314-362-8089
[email protected]
Benjamin D Kozower, M.D., MPH
Principal Investigator
Varun Puri, M.D., MSCI
Sub-Investigator
Cliff Robinson, M.D.
Sub-Investigator
Esther Lu, Ph.D.
Sub-Investigator
Margaret Olsen, Ph.D., MPH
Sub-Investigator
Memorial Sloan Kettering
New York New York, 10065, United States More Info
David Jones, M.D.
Contact
212-639-2000
David Jones, M.D.
Principal Investigator
Narek Shaverdian, M.D.
Sub-Investigator
Duke University
Durham North Carolina, 27710, United States More Info
David Harpole, M.D.
Contact
919-668-8413
David Harpole, M.D.
Principal Investigator
Joseph Salama, M.D.
Sub-Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Alejandro Bribriesco, M.D.
Contact
216-445-8140
Alejandro Bribriesco, M.D.
Principal Investigator
Kevin Stephens, M.D.
Sub-Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ara Vaporciyan, M.D.
Contact
877-284-1820
Ara Vaporciyan, M.D.
Principal Investigator
Joe Chang, M.D., Ph.D.
Sub-Investigator
University of Toronto
Toronto Ontario, , Canada More Info
Thomas Waddell, M.D., Ph.D.
Contact
416-978-2011
Thomas Waddell, M.D., Ph.D.
Principal Investigator
Alexander Sun, M.D.
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

438

Study ID:

NCT05183932

Recruitment Status:

Recruiting

Sponsor:


Washington University School of Medicine

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