Magnetic Resonance Imaging for Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Small Cell Lung Cancer+2 MoreMagnetic Resonance Imaging - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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: Procedure
Arm 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?
Texas50.0%
Louisiana50.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
East Jefferson General Hospital50.0%
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%