Comparison of Surgery to Stereotactic Body Radiation Therapy (SBRT) in Patients With Stage I Non-Small Cell Lung Cancer
18 Years and older, Male and Female
202112102-1001 (primary)
NCI-2022-00200
Summary
This study compares the results of surgery to stereotactic body radiation therapy (SBRT) in patients with stage I non-small cell lung cancer (NSCLC). Both surgery and SBRT are standard treatments for this kind of lung cancer. Surgery removes the cancer but is more invasive and may have more complications. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Information gathered from this study may help researchers find out if SBRT is as effective as surgery in treating patients with stage I NSCLC.
Objectives
PRIMARY OBJECTIVES:
I. To compare disease-free survival between surgery and SBRT in stage I NSCLC patients.
II. To compare short- and long-term patient-reported outcomes between surgery and SBRT in stage I NSCLC patients.
SECONDARY OBJECTIVE:
I. To develop and validate prediction models for treatment outcomes for an individual patient with stage I NSCLC.
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups as determined by the treating provider.
GROUP I (SURGERY): Patients undergo surgery as per standard of care on study. Patients also undergo assessment of frailty and medical chart review during screening as well as complete patient reported outcomes questionnaires pre- and post-treatment throughout study.
GROUP II (SBRT): Patients undergo SBRT as per standard of care on study. Patients also undergo assessment of frailty and medical chart review during screening as well as complete patient reported outcomes questionnaires pre- and post- treatment throughout the study.
Eligibility
- Clinical stage I NSCLC (T1 or T2a, N0, M0) by computed tomography (CT) scan performed within 90 days of treatment.
* Positron emission tomography (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 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.
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- No home oxygen use
- Forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% predicted measured within 2 years of enrollment
- No symptomatic congestive heart failure as documented by New York Heart Association (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 institutional review board (IRB)-approved written informed consent document.
- Agrees to receive treatment for clinical stage I NSCLC (either surgical resection or SBRT)
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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