A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Oligometastatic Disease
The goal of this clinical research study is to learn if surgery or radiation after chemotherapy can help to control NSCLC. The safety of this treatment will also be studied.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Oligometastatic Disease|
- Progression-Free Survival (PFS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]Progression-free survival (PFS) defined as time from the time of randomization (LCT vs. no LCT) to disease progression or death. For the primary endpoint, PFS, Kaplan-Meier estimate will be computed and the log-rank test will be performed to compare the difference of PFS between the two arms.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||November 2019 (Final data collection date for primary outcome measure)|
Experimental: Local Consolidation Therapy (LCT)
Patients receive local consolidation therapy (LCT) after induction chemotherapy. LCT is radiation, surgery, or both. If assigned to the LCT group, the study doctor will decide if patient has radiation alone, surgery alone, or radiation combined with surgery.
Patients receive local consolidation therapy (LCT) after induction chemotherapy. LCT is radiation, surgery, or both. If assigned to the LCT group, study doctor will decide if patient has radiation alone, surgery alone, or radiation combined with surgery.
Radiation therapy delivered using external beam radiation, with either 2D/conventional techniques, three-dimensional conformal therapy, intensity modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS) or proton beam therapy (PBT), at discretion of treating radiation oncologist.
Surgical control of primary and metastatic sites of disease may include control of either or both sites of disease as determined by multidisciplinary group (medical oncologist, radiation oncologist, and surgeon).
Active Comparator: No Local Consolidation Therapy (LCT)
Patients randomized to the no LCT arm receive maintenance therapy (switch or continuation), or surveillance, based on physician choice after induction chemotherapy. Pemetrexed, bevacizumab, crizotinib (for ALK-mutation positive patients) or erlotinib are recommended as acceptable maintenance agents but other agents may be used at physician discretion.
Other: No LCT
No surgery or radiation therapy right after induction chemotherapy. Patients receive either systemic therapy (i.e. chemotherapy) or observation. The care received will depend on discretion of doctor.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01725165
|Contact: Daniel Gomez, MD||713-563-2300|
|United States, Colorado|
|University of Colorado||Recruiting|
|Denver, Colorado, United States, 80204|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||Daniel Gomez, MD||M.D. Anderson Cancer Center|