A Phase III Study of Sublobar Resection versus Stereotactic Body Radiation Therapy in High-Risk Patients with Stage I Non-Small Cell Lung Cancer

Protocol
13-003
Full Title
A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC) (ACOSOG Z4099 / RTOG 1021)
Purpose

Patients with stage I non-small cell lung cancer typically have surgery to remove the lung lobe containing the cancer. However, for some patients, the surgery is too risky, so surgeons perform a “sublobar resection” to remove a smaller portion of lung tissue.

In this study, researchers are comparing sublobar resection to another form of treatment called stereotactic body radiation therapy (SBRT) in patients with suspicious lung nodules or early-stage non-small cell lung cancer. SBRT uses fewer but higher and more targeted doses of radiation therapy to destroy cancer cells. However, it is not known if SBRT is as effective as sublobar resection for reducing the risk of lung cancer recurrence and improving survival.

Patients in this study will be randomly assigned to one of two groups. One group will undergo sublobar section, and the other will receive SBRT. Researchers will compare outcomes between the two groups.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a lung nodule that is suspicious for cancer or stage I non-small cell lung cancer that is in the periphery of the lungs.
  • Patients must be determined to be at high risk but eligible for surgery because of age (75 or older) or other medical conditions.
  • Patients may not have had prior treatment for this specific lung nodule.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Daphna Gelblum at 631-623-4200.

Disease(s)
Lung Cancer
Lung Cancer, Non-Small Cell