Study Summary
This trial looks at whether monitoring with MRI scans alone is as good as the combination of PCI with MRI scans for treating patients with small cell lung cancer.
Eligible Conditions
- Small Cell Lung Cancer
- Extensive Stage Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization
Day 720
CFFS rate
Month 12
Cognitive failure-free survival (CFFS)
Year 2
Overall survival (OS)
Year 2
OS in an "as-treated" analysis
Day 720
Cumulative incidence of cognitive failure
Year 2
Incidence of adverse events
Year 2
Brain metastases-free survival (BMFS)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Arm I (PCI, MRI)
1 of 2
Arm II (MRI)
1 of 2
Active Control
Experimental Treatment
668 Total Participants · 2 Treatment Groups
Primary Treatment: Magnetic Resonance Imaging · No Placebo Group · Phase 3
Arm II (MRI)
Procedure
Experimental Group · 1 Intervention: Magnetic Resonance Imaging · Intervention Types: ProcedureArm I (PCI, MRI)ActiveComparator Group · 2 Interventions: Magnetic Resonance Imaging, Prophylactic Cranial Irradiation · Intervention Types: Procedure, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to first neurocognitive failure cf or death due to any cause, assessed up to 12 months after randomization
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,128,154 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
386 Previous Clinical Trials
260,985 Total Patients Enrolled
Chad G RusthovenPrincipal InvestigatorSouthwest Oncology Group
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have not had an adverse event from prior treatment.\n
Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator.
Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy
Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies.
You have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease
Patients with limited-stage (LS)-SCLC must have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including stereotactic body radiation therapy [SBRT] for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not required.
Who else is applying?
What state do they live in?
| Texas | 50.0% |
| Louisiana | 50.0% |
How old are they?
| 65+ | 50.0% |
| 18 - 65 | 50.0% |
What site did they apply to?
| East Jefferson General Hospital | 50.0% |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments