Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients with Early Stage Non-Small Lung Cancer (NSCLC)

Overview

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.

Participation eligibility

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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:

Major Criteria:

  • Forced expiratory volume in one second (FEV1) ≤ 50% predicted
  • Carbon monoxide diffusing capacity (DLCO) ≤ 50% predicted

Minor Criteria:

  • 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.

Exclusion Criteria

  • 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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Dennis Wigle, M.D., Ph.D.

Closed for enrollment

More information

Publications

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