Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients with Early Stage Non-Small Lung Cancer (NSCLC)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 11-000805
NCT ID: NCT01622621
Sponsor Protocol Number: 11-000805
About this study
This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. SBRT is less invasive and felt to be equally effective to surgery for early stage NSCLC. Surgery is currently the standard of care for these patients. The hypothesis of this study is that SBRT is at least as good as surgery for disease free survival at 2 years.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patients must have a suspicious lung nodule for clinical stage I NSCLC.
- Pathologic confirmation at the time of surgery is acceptable. Patients randomized to SBRT require core biopsy for diagnosis prior to treatment.
- Patient must have a mass ≤ 5 cm maximum diameter by CT size estimate that is clinical stage I (T1N0, T2N0)
- Patient must have a CT scan of the chest and upper abdomen and PET-scan within 60 days prior to date of registration.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) or Zubrod performance status 0, 1, or 2.
- Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:
- Forced expiratory volume in one second (FEV1) ≤ 50% predicted
- Carbon monoxide diffusing capacity (DLCO) ≤ 50% predicted
- Age ≥75
- FEV1 51-60% predicted
- DLCO 51-60% predicted
- Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
- Poor left ventricular function (defined as an ejection fraction of 40% or less)
- Resting or Exercise Arterial oxygen partial pressure (pO2) ≤ 55 mm Hg or blood oxygen saturation (SpO2) ≤ 88%
- pCO2 > 45 mm Hg
- Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3.
- Patient must not have had previous intra-thoracic radiation therapy.
- No prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer, stage 0 Chronic lymphocytic leukemia (CLL), or other cancer disease-free > 3 yrs.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Dennis Wigle, M.D., Ph.D.
Open for enrollment
Thoracic Surgery Research Unit