Metastatic Malignant Neoplasm in the Brain Clinical Trial
Official title:
A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
Verified date | January 2024 |
Source | NRG Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.
Status | Recruiting |
Enrollment | 236 |
Est. completion date | March 16, 2032 |
Est. primary completion date | March 16, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration - The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure > 2.0 cm and < 5.0 cm. - The maximum diameter of the lesions not to be resected must measure < 4.0 cm - Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years - All brain metastases must be located > 5 mm from the optic chiasm and outside the brainstem - Patient is able to medically tolerate surgery and SRS - The lesion chosen for surgical therapy must be deemed an appropriate target for safe, gross total resection by the treating surgeon - History/physical examination within 14 days prior to registration - Age >= 18 - Karnofsky performance status (KPS) >= 60 within 14 days prior to registration - A negative urine or serum pregnancy test (in persons of childbearing potential) within =< 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months - Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information Exclusion Criteria: - Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site - Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed - Evidence of leptomeningeal disease (LMD) - Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion - Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery - Primary histology of germ cell tumor, small cell carcinoma or lymphoma - More than one brain metastasis planned for resection - Inability to undergo MRI with contrast - Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS - Note: chemotherapy and immunotherapy outside of this window are allowed |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Advocate Good Shepherd Hospital | Barrington | Illinois |
United States | Indu and Raj Soin Medical Center | Beavercreek | Ohio |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Montefiore Medical Center-Einstein Campus | Bronx | New York |
United States | Montefiore Medical Center-Weiler Hospital | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina |
United States | UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida |
United States | AMG Crystal Lake - Oncology | Crystal Lake | Illinois |
United States | Carle at The Riverfront | Danville | Illinois |
United States | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Advocate Good Samaritan Hospital | Downers Grove | Illinois |
United States | Northeast Radiation Oncology Center | Dunmore | Pennsylvania |
United States | Carle Physician Group-Effingham | Effingham | Illinois |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Inova Schar Cancer Institute | Fairfax | Virginia |
United States | Weisberg Cancer Treatment Center | Farmington Hills | Michigan |
United States | Gibbs Cancer Center-Gaffney | Gaffney | South Carolina |
United States | CaroMont Regional Medical Center | Gastonia | North Carolina |
United States | Aurora Health Care Germantown Health Center | Germantown | Wisconsin |
United States | Aurora Cancer Care-Grafton | Grafton | Wisconsin |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | Gibbs Cancer Center-Pelham | Greer | South Carolina |
United States | Advocate South Suburban Hospital | Hazel Crest | Illinois |
United States | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | AMG Libertyville - Oncology | Libertyville | Illinois |
United States | Covenant Medical Center-Lakeside | Lubbock | Texas |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Miami Cancer Institute | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Aurora Sinai Medical Center | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Mount Sinai Chelsea | New York | New York |
United States | Mount Sinai Hospital | New York | New York |
United States | Mount Sinai West | New York | New York |
United States | Cancer Care Center of O'Fallon | O'Fallon | Illinois |
United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin |
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
United States | The Valley Hospital-Luckow Pavilion | Paramus | New Jersey |
United States | Advocate Lutheran General Hospital | Park Ridge | Illinois |
United States | Capital Health Medical Center-Hopewell | Pennington | New Jersey |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Saint Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | UPMC-Presbyterian Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania |
United States | Aurora Cancer Care-Racine | Racine | Wisconsin |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Ascension Saint Mary's Hospital | Rhinelander | Wisconsin |
United States | CJW Medical Center - Johnston-Willis Campus | Richmond | Virginia |
United States | Henrico Doctor's Hospital | Richmond | Virginia |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Valley Hospital | Ridgewood | New Jersey |
United States | University of Rochester | Rochester | New York |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | Ascension Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Aurora Medical Center in Summit | Summit | Wisconsin |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | Banner University Medical Center - Tucson | Tucson | Arizona |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | MGC Hematology Oncology-Union | Union | South Carolina |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois |
United States | UW Cancer Center at ProHealth Care | Waukesha | Wisconsin |
United States | Aspirus Regional Cancer Center | Wausau | Wisconsin |
United States | Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | Good Samaritan University Hospital | West Islip | New York |
United States | Valley Health System-Hematology/Oncology | Westwood | New Jersey |
United States | Novant Health Cancer Institute Radiation Oncology - Wilmington | Wilmington | North Carolina |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
NRG Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Type of surgical resection | Will compare if the type of surgical resection (piece-meal vs. en-bloc) may be associated with the rate of nodular meningeal disease. The competing risk approach by Gray (Gray 1988) will be used to compare the cumulative incidences of nMD by surgical type, where death prior to nMD will be treated as a competing risk event. | Up to 4 years | |
Primary | Time to Composite Adverse Endpoint (CAE) | Analysis for this endpoint will consist of testing the cause-specific hazard ratio in a Cox proportional hazards model. | Time from surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment) to local tumor progression (within the surgical bed), nodular meningeal disease, or radiation necrosis, whichever occurs first, assessed up to 4 years | |
Secondary | Overall Survival (OS) | Analysis for this endpoint will consist of estimation of the OS distribution of each treatment arm via the Kaplan-Meier method and a stratified log-rank test. | Time from randomization to death due to any cause, assessed up to 4 years | |
Secondary | Rate of local tumor progression | The time origin for these imaging-based endpoints will be time of surgery (with the post-operative magnetic resonance imaging [MRI] as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures between treatment arms. | Up to 4 years | |
Secondary | Rate of radiation necrosis | The time origin for these imaging-based endpoints will be time of surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures between treatment arms. | Up to 4 years | |
Secondary | Rate of nodular meningeal disease | The time origin for these imaging-based endpoints will be time of surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures between treatment arms. | Up to 4 years | |
Secondary | Rate of distant brain failures | The time origin for these imaging-based endpoints will be time of surgery (with the post-operative MRI as the 'baseline' for purposes of disease assessment). These analyses will involve estimating the cumulative incidence function of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures in the presence of competing event of deaths. The Gray's test will be used to evaluate the difference in the distribution of local progression, radiation necrosis, nodular meningeal disease, and distant brain failures between treatment arms. | Up to 4 years | |
Secondary | Frequency of adverse events (AEs) | AEs will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Comprehensive summaries of all AEs by treatment arm will be generated and examined. Counts and frequencies of worst (highest score) AE per patient will be presented overall and by AE type category, separately by assigned treatment group. The proportion of patients with at least one grade 3 or higher AE will be compared between treatment arms. Any frequencies to be tested will be evaluated using the chi-square or exact test as appropriate, with two-sided significance level 0.05. | Up to 4 years | |
Secondary | Change in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) | Will implement mixed effects models for repeated measures to evaluate the MDASI-BT scores longitudinally. | Baseline up to 2 years after surgery | |
Secondary | Change in cognitive function | Measured by Montreal Cognitive Assessment (MoCA). Will implement mixed effects models for repeated measures to evaluate the MoCA scores longitudinally. | Baseline up to 2 years after surgery |
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