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Radiation Therapy

MRI Monitoring vs. Preventive Brain Radiation for Small Cell Lung Cancer

Phase 3
Recruiting
Led By Chad G Rusthoven
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease
Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to first neurocognitive failure cf or death due to any cause, assessed up to 12 months after randomization
Awards & highlights

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.

Who is the study for?
This trial is for adults with small cell lung cancer (SCLC) who've responded to first-line therapy without disease progression. They must have good organ function, no metal implants or allergies that make MRI unsafe, and not be receiving treatment for other cancers. HIV-positive patients can join if treated and stable. Pregnant women are excluded, and participants must agree to use contraception.Check my eligibility
What is being tested?
The study compares two approaches: one group will be monitored with brain MRIs alone, while the other will receive preventive brain radiation plus MRI monitoring. The goal is to see if avoiding early radiation can extend life without increasing cancer spread risks.See study design
What are the potential side effects?
MRI scans are generally safe but may cause discomfort or anxiety in some people. Preventive cranial irradiation could lead to hair loss, skin changes on the scalp, fatigue, headaches, memory problems or cognitive decline.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had a brain MRI recently showing no brain metastases or leptomeningeal disease.
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My diagnosis is small-cell lung cancer.
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I do not have any other cancers that need treatment right now.
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I can take care of myself and am up and about more than 50% of my waking hours.
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All side effects from my previous treatments are mild now.
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It has been less than 8 weeks since my last chemotherapy session.
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I am HIV positive with a CD4 count below 200.
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I can safely receive gadolinium contrast for MRIs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to first neurocognitive failure cf or death due to any cause, assessed up to 12 months after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to first neurocognitive failure cf or death due to any cause, assessed up to 12 months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Brain metastases-free survival (BMFS)
CFFS rate
Cognitive failure-free survival (CFFS)
+3 more

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293
19%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
11600-Alanine aminotransferase increased
8%
16800-Bladder infection
8%
44800-Infections and infestations - Other specify
8%
58700-Nystagmus
4%
15000-Aspartate aminotransferase increased
4%
88500-White blood cell decreased
4%
15300-Ataxia
4%
33900-Fever
4%
25700-Diarrhea
4%
43100-Hypokalemia
4%
69700-Rash maculo-papular(targeted toxicity)
4%
13200-Anemia
4%
33300-Febrile neutropenia
4%
57600-Nausea(targeted toxicity)
4%
20500-Catheter related infection
4%
58300-Neutrophil count decreased
4%
41300-Hypercalcemia
4%
41400-Hyperglycemia(targeted toxicity)
4%
41600-Hyperkalemia
4%
42600-Hypoalbuminemia
4%
42700-Hypocalcemia
4%
64400-Personality change
4%
41500-Hyperhidrosis
4%
13500-Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (MRI)Experimental Treatment1 Intervention
Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
Group II: Arm I (PCI, MRI)Active Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
263,952 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,715 Previous Clinical Trials
40,953,181 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,593 Total Patients Enrolled

Media Library

Prophylactic Cranial Irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04155034 — Phase 3
Small Cell Lung Cancer Research Study Groups: Arm II (MRI), Arm I (PCI, MRI)
Small Cell Lung Cancer Clinical Trial 2023: Prophylactic Cranial Irradiation Highlights & Side Effects. Trial Name: NCT04155034 — Phase 3
Prophylactic Cranial Irradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04155034 — Phase 3
Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT04155034 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different hospitals are running this study today?

"Currently, this research is being conducted at 100 hospitals, with several locations in Omaha, Salt Lake City, and Louisville. It is recommended that you choose the hospital closest to you to minimize travel time and costs if you enroll in the study."

Answered by AI

Are people still signing up to participate in this clinical trial?

"The information available on clinicaltrials.gov does show that this study is still open to recruiting new patients. This particular trial was first posted on January 10th, 2020 and was last updated on July 20th, 2020. They are looking for a total of 668 participants, which will be recruited from 100 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Florida
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
East Jefferson General Hospital
Community Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need treatment asap.
PatientReceived no prior treatments
~172 spots leftby Nov 2025