Clinical Trial TitleMaintenance systemic therapy versus local consolidative therapy (LCT) plus maintenance systemic therapy for limited metastatic non-small cell lung cancer (NSCLC): A randomized phase II/III trial.
Clinical Trial Protocol Description:
This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration. This includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases.
- Have a Zubrod performance status of 0, 1, or 2 within 30 days prior to registration.
- Have received first-line/induction chemotherapy (4 cycles) and achieved stable disease or a partial response.
- Have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to SBRT.
This is a partial list of inclusion and exclusion criteria.