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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

Pivotal Trial

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to first neurocognitive failure cf or death due to any cause, assessed up to 12 months after randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

Secondary study objectives

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

58700-Nystagmus

16800-Bladder infection

11600-Alanine aminotransferase increased

44800-Infections and infestations - Other specify

58300-Neutrophil count decreased

41400-Hyperglycemia(targeted toxicity)

69700-Rash maculo-papular(targeted toxicity)

33900-Fever

33300-Febrile neutropenia

20500-Catheter related infection

42600-Hypoalbuminemia

43100-Hypokalemia

88500-White blood cell decreased

41300-Hypercalcemia

42700-Hypocalcemia

15300-Ataxia

64400-Personality change

13200-Anemia

57600-Nausea(targeted toxicity)

13500-Anorexia

15000-Aspartate aminotransferase increased

25700-Diarrhea

41600-Hyperkalemia

41500-Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met