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
Launched by SWOG CANCER RESEARCH NETWORK · Nov 5, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The S1827 (MAVERICK) clinical trial is studying whether using brain scans alone, instead of combining brain scans with preventive brain radiation, can help patients with small cell lung cancer live longer. The goal is to see if monitoring with MRI scans can be just as effective as using radiation therapy to prevent cancer from spreading to the brain, while also reducing side effects. This trial is open to adults aged 65 to 74 who have been diagnosed with small cell lung cancer, have no signs of cancer in the brain, and have responded well to their initial treatment.
Participants in this trial can expect to undergo regular MRI scans to check for any changes in their condition. They will not receive brain radiation unless it is deemed necessary later on. It’s important for potential participants to meet certain health criteria, such as having no recent serious health issues and being able to undergo MRI scans safely. Those who join the study will be closely monitored and will have the opportunity to contribute to valuable research that could impact future treatments for small cell lung cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- • Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization
- • Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
- • Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter
- • Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 16 weeks prior to randomization
- • Note also that HIV testing is not required for eligibility for this protocol
- • Patient must not be pregnant because of fetal risks from radiation exposure. Men must have agreed to use an effective contraceptive method during PCI and for six months after completing PCI. Women of reproductive potential must have agreed to use an effective contraceptive method during PCI. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- • Patients who speak and understand English or French must agree to participate in cognitive function testing
- • Patient must be offered the opportunity to have specimens submitted for banking
- • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- • As a part of the Oncology Patient Enrollment Network (OPEN) randomization process the treating institution?s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
New Haven, Connecticut, United States
Cleveland, Ohio, United States
Milwaukee, Wisconsin, United States
Boston, Massachusetts, United States
Buffalo, New York, United States
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Maywood, Illinois, United States
Riyadh, , Saudi Arabia
Peoria, Illinois, United States
Detroit, Michigan, United States
Toms River, New Jersey, United States
Hamilton, Ontario, Canada
Oshawa, Ontario, Canada
Regina, Saskatchewan, Canada
Boston, Massachusetts, United States
San Francisco, California, United States
Winnipeg, Manitoba, Canada
Wichita, Kansas, United States
Oklahoma City, Oklahoma, United States
Duarte, California, United States
Des Moines, Iowa, United States
La Crosse, Wisconsin, United States
Long Branch, New Jersey, United States
Baltimore, Maryland, United States
Greeley, Colorado, United States
Loveland, Colorado, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Kalispell, Montana, United States
Delaware, Ohio, United States
Chicago, Illinois, United States
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Fort Collins, Colorado, United States
Salina, Kansas, United States
Bryn Mawr, Pennsylvania, United States
Urbana, Illinois, United States
Annapolis, Maryland, United States
Ann Arbor, Michigan, United States
Shakopee, Minnesota, United States
Grand Forks, North Dakota, United States
Effingham, Illinois, United States
Lawrence, Kansas, United States
Bethlehem, Pennsylvania, United States
Clearwater, Florida, United States
Springfield, Illinois, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
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Media, Pennsylvania, United States
Summit, New Jersey, United States
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Tampa, Florida, United States
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Birmingham, Alabama, United States
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Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Saint Cloud, Minnesota, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
New Brunswick, New Jersey, United States
Bronx, New York, United States
New York, New York, United States
Syracuse, New York, United States
Winston Salem, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Newark, Delaware, United States
Lexington, Kentucky, United States
Bronx, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Morgantown, West Virginia, United States
Cape Girardeau, Missouri, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Robbinsdale, Minnesota, United States
Memphis, Tennessee, United States
Omaha, Nebraska, United States
Glens Falls, New York, United States
Matthews, North Carolina, United States
Louisville, Kentucky, United States
Milwaukee, Wisconsin, United States
Oak Lawn, Illinois, United States
Miami, Florida, United States
Park Ridge, Illinois, United States
Royal Oak, Michigan, United States
Albuquerque, New Mexico, United States
Stony Brook, New York, United States
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St. John's, Newfoundland And Labrador, Canada
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Des Moines, Iowa, United States
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Wilkes Barre, Pennsylvania, United States
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Paoli, Pennsylvania, United States
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Canandaigua, New York, United States
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'Aiea, Hawaii, United States
Honolulu, Hawaii, United States
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Ames, Iowa, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
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Chadds Ford, Pennsylvania, United States
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Greeley, Colorado, United States
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Salisbury, North Carolina, United States
Hamden, Connecticut, United States
Ocean Pines, Maryland, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Crown Point, Indiana, United States
Dyer, Indiana, United States
Hobart, Indiana, United States
Hobart, Indiana, United States
Munster, Indiana, United States
Valparaiso, Indiana, United States
East Norriton, Pennsylvania, United States
Williamsport, Pennsylvania, United States
Newnan, Georgia, United States
Regina, Saskatchewan, Canada
Neenah, Wisconsin, United States
New London, Wisconsin, United States
Shawano, Wisconsin, United States
Waupaca, Wisconsin, United States
Forest City, North Carolina, United States
Highlands Ranch, Colorado, United States
Oshkosh, Wisconsin, United States
Pierre, South Dakota, United States
Alton, Illinois, United States
Annapolis, Maryland, United States
Greeley, Colorado, United States
Alpharetta, Georgia, United States
Canton, Georgia, United States
'Aiea, Hawaii, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Perrysburg, Ohio, United States
Aurora, Colorado, United States
Independence, , Chile
Shiloh, Illinois, United States
Yankton, South Dakota, United States
Berlin, Wisconsin, United States
Des Moines, Iowa, United States
Kalispell, Montana, United States
Moon, Pennsylvania, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Danville, Illinois, United States
Guilford, Connecticut, United States
Greenville, Ohio, United States
Los Angeles, California, United States
Ames, Iowa, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Ladysmith, Wisconsin, United States
Minocqua, Wisconsin, United States
Columbia, Missouri, United States
Verona, New York, United States
Sunset Hills, Missouri, United States
O'fallon, Illinois, United States
Lincoln, Nebraska, United States
Lincolnton, North Carolina, United States
Loveland, Colorado, United States
Rockford, Illinois, United States
Jefferson City, Missouri, United States
Fort Thomas, Kentucky, United States
Pontiac, Michigan, United States
Dayton, Ohio, United States
Royal Oak, Michigan, United States
Dearborn, Michigan, United States
Farmington Hills, Michigan, United States
Troy, Michigan, United States
North Wilkesboro, North Carolina, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Camillus, New York, United States
Detroit, Michigan, United States
Warren, Michigan, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Corona, California, United States
Rolla, Missouri, United States
Portland, Maine, United States
Scarborough, Maine, United States
Patients applied
Trial Officials
Chad G Rusthoven
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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