This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.
PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms. II. To compare brain-metastasis-free survival between the arms. III. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease. IV. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms. V. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms. VI. To compare the frequency and severity of toxicities between the two arms. ADDITIONAL OBJECTIVE: I. To collect blood for banking. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months. ARM II: Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
668
Undergo MRI
Undergo PCI
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGKatmai Oncology Group
Anchorage, Alaska, United States
RECRUITINGFairbanks Memorial Hospital
Fairbanks, Alaska, United States
SUSPENDEDUniversity of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
Overall survival (OS)
Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).
Time frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization
Cognitive failure-free survival (CFFS)
The comparison of CFFS up to 12 months between the arms will be done using a 1-sided 5% level log-rank test.
Time frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization
CFFS rate
There will be a comparison of the CFFS rates between the arms at each of the assessment times and the cumulative incidence of cognitive failure, evaluating death as a competing risk. The CFFS rates at the landmark times will be estimated using the method of Kaplan-Meier and the difference in rates will be evaluated using a 90% confidence interval using Greenwood?s formula.
Time frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization
Cumulative incidence of cognitive failure
The cumulative incidence of cognitive failure in the presence of the competing risk of death will be estimated used the method of Fine and Gray.
Time frame: Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization
OS in an "as-treated" analysis
The comparison of OS in the ?as-treated? analysis will be done as described for the primary analysis, however patients will be categorized per treatment received (patients who do not accept their randomized assignment will be analyzed per treatment received). The number of patients not accepting the randomized assignment will also be summarized.
Time frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization. Patients will be seen at day 90, 180, 270, 360, 540, and 720
Brain metastases-free survival (BMFS)
This will be estimated using the method of Kaplan-Meier and comparisons will be done using a log-rank test at the 1-sided 0.05 level. Hazard ratios and associated confidence intervals will be estimated using a Cox Proportional hazards model. Confidence intervals for medians will be estimated using the method of Brookmeyer-Crowley.
Time frame: Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720
Incidence of adverse events
Binary proportions and associated confidence intervals will be estimated.
Time frame: Up to 2 years after randomization. Patients will be assessed for adverse event after PCI (for patients on PCI + MRI arm) and at month 3 (all patients)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
ACTIVE_NOT_RECRUITINGCity of Hope Corona
Corona, California, United States
ACTIVE_NOT_RECRUITINGCity of Hope Comprehensive Cancer Center
Duarte, California, United States
ACTIVE_NOT_RECRUITINGVeterans Affairs Loma Linda Healthcare System
Loma Linda, California, United States
RECRUITINGTibor Rubin VA Medical Center
Long Beach, California, United States
RECRUITINGLos Angeles General Medical Center
Los Angeles, California, United States
RECRUITING...and 436 more locations