NCT04155034|RecruitingPhase 3DMCFDA Device

S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S1827NCI-2019-05338U10CA180888

Study Type

interventional

Target

668

Locations

7 countries

Sites

446

Timeline

RegisteredNov 2019

StartedMay 2020

CompletionNov 2029

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

668

participants targeted

Target at P75+ for phase_3

Timeline

43mo left

Started May 2020

Longer than P75 for phase_3

Geographic Reach

7 countries

446 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.5 years study duration

Study Progress63%

May 2020Nov 2029

First Submitted

Initial submission to the registry

November 5, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed

6 months until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed

6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2029

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

6.5 years

First QC Date

November 5, 2019

Last Update Submit

May 20, 2025

Conditions

Extensive Stage Lung Small Cell Carcinoma Limited Stage Lung Small Cell Carcinoma Lung Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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).
From the date of registration to date of death due to any cause, assessed up to 2 years after randomization

Secondary Outcomes (6)

Cognitive failure-free survival (CFFS)
Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization
CFFS rate
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
Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization
OS in an "as-treated" analysis
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)
Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720
+1 more secondary outcomes

Study Arms (2)

Arm I (PCI, MRI)

ACTIVE COMPARATOR

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.

Procedure: Magnetic Resonance ImagingRadiation: Prophylactic Cranial Irradiation

Arm II (MRI)

EXPERIMENTAL

Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

Procedure: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Arm I (PCI, MRI)Arm II (MRI)

Prophylactic Cranial IrradiationRADIATION

Undergo PCI

Also known as: PCI

Arm I (PCI, MRI)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient must 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. Patient also must not have a history of brain metastases or leptomeningeal disease
Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. 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. Patients with extensive-stage (ES)-SCLC must have completed platinum-based chemotherapy either with or without thoracic radiotherapy at the discretion of the treating physician
All adverse events from prior treatment must have resolved to =\< grade 2 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) prior to randomization
Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (computed tomography \[CT\] or positron emission tomography \[PET\]/CT including the chest and abdomen) must be performed within 28 days prior to randomization
No more than 8 weeks may have elapsed between day 1 of the last cycle of chemotherapy and randomization
Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis
Patient must have Zubrod performance status of 0-2
Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Patient must not have other metastatic malignancies requiring current active treatment
Patient must not have any severe active comorbidities, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
Transmural myocardial infarction within 6 months prior to randomization
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
+10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (446)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

ACTIVE NOT RECRUITING

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

RECRUITING

Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

SUSPENDED

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, United States

ACTIVE NOT RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

ACTIVE NOT RECRUITING

City of Hope Corona

Corona, California, 92882, United States

ACTIVE NOT RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

ACTIVE NOT RECRUITING

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California, 92357, United States

RECRUITING

Tibor Rubin VA Medical Center

Long Beach, California, 90822, United States

RECRUITING

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

ACTIVE NOT RECRUITING

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

RECRUITING

City of Hope South Pasadena

South Pasadena, California, 91030, United States

ACTIVE NOT RECRUITING

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States

RECRUITING

Banner North Colorado Medical Center

Greeley, Colorado, 80631, United States

RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States

RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

RECRUITING

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

RECRUITING

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

Banner McKee Medical Center

Loveland, Colorado, 80539, United States

RECRUITING

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

RECRUITING

Smilow Cancer Hospital-Hamden Care Center

Hamden, Connecticut, 06518, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

RECRUITING

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, 06516, United States

RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States

ACTIVE NOT RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

ACTIVE NOT RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

ACTIVE NOT RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

ACTIVE NOT RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

ACTIVE NOT RECRUITING

John Fitzgerald Kennedy Medical Center

Atlantis, Florida, 33462, United States

RECRUITING

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

ACTIVE NOT RECRUITING

Morton Plant Hospital

Clearwater, Florida, 33756, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States

ACTIVE NOT RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Northside Hospital-Alpharetta

Alpharetta, Georgia, 30005, United States

SUSPENDED

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Northside Hospital-Cherokee

Canton, Georgia, 30115, United States

RECRUITING

John B Amos Cancer Center

Columbus, Georgia, 31904, United States

ACTIVE NOT RECRUITING

Northside Hospital-Forsyth

Cumming, Georgia, 30041, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

ACTIVE NOT RECRUITING

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

RECRUITING

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza