The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.
This protocol is a randomized phase II trial of maintenance chemotherapy versus consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy for patients with Stage IV non-small cell lung cancer (NSCLC). Prior to accrual on the trial, patients with Stage IV NSCLC will be treated with standard first-line chemotherapy. Patients who achieve a partial response or stable disease by imaging criteria with fewer than or equal to six sites of oligometastatic disease will be randomized to maintenance chemotherapy or consolidative SBRT to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of first line and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Maintenance chemotherapy
UT Southwestern Medical Center
Dallas, Texas, United States
Progression Free Survival
Evaluate the effect of SBRT with maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival. Time to the development of new lesions, progression of existing lesions, or death, whichever came first, represented the primary end point of progression-free survival. All evaluations of disease response used RECIST (v1.1) criteria, in which progressive disease is defined as "At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
Time frame: 5 years
In-field Local Control Versus Out-of-field Disease Progression
Number of occurances of in-field local control and rate of out-of-field disease progression
Time frame: 5 years
Toxicities
To evaluate the safety of SBRT with metastatic NSCLC after prior chemotherapy
Time frame: 2 years
Overall Survival
To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.
Time frame: 5 years
Duration of Maintenance Chemotherapy
To evaluate the duration of maintenance chemotherapy and time to initiation of third line systemic agent (chemotherapy or biologic agent)
Time frame: 5 years
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