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Clinical Trials (PDQ®)

Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherN107C
NCCTG-N107C, CDR0000701474, NCI-2011-02676, NCT01372774

Trial Description

Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

Further Study Information

OBJECTIVES:

Primary

  • To ascertain in patients with one to four brain metastases whether there is improved overall survival in patients who receive stereotactic radiosurgery (SRS) to the surgical bed compared to patients who receive whole-brain radiotherapy (WBRT).
  • To ascertain in patients with one to four brain metastases whether there is less neurocognitive progression at 6 months post-radiation in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

Secondary

  • To ascertain in patients with resected brain metastases whether there is improved quality-of-life (QOL) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  • To ascertain in patients with one to four brain metastases whether there is equal longer time to central nervous system (CNS) failure (brain) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  • To ascertain in patients with one to four brain metastases whether there is longer duration of functional independence in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  • To ascertain in patients with one to four brain metastases whether there is better long-term neurocognitive status in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  • To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.
  • To evaluate local tumor bed recurrence at 6 months with post-surgical SRS to the surgical bed in comparison to WBRT.
  • To evaluate time to local recurrence with post-surgical SRS to the surgical bed in comparison to WBRT.
  • To evaluate if there is any difference in CNS failure patterns (local, distant, leptomeningeal) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.

Exploratory

  • To evaluate radiation changes in the limbic system that may correlate with neurotoxicity using brain MRI scans.
  • To determine whether Apo E (i.e., Apo E2, Apo E3, and Apo E4) genotyping may prove to be a predictor of radiation-induced neurocognitive decline (or neuroprotection).
  • To determine whether inflammatory markers (i.e., IL-1, IL-6, and TNF-α) may prove to be predictors of radiation-induced neurocognitive decline.
  • To determine whether oxidative stress biomarkers (i.e., protein carbonyl content, lipid hydroperoxides, and isoprostane levels) may prove to be predictors of radiation-induced neurocognitive decline.
  • To determine whether hormone and growth factors [i.e., glucocorticoids (e.g., cortisol), gonadal steroids (e.g., estradiol, testosterone, progesterone), growth hormone, human chorionic gonadotropin (hCG), insulin-like growth factor-1 (IGF-1), and neuronal growth factor (NGF)] may prove to be a predictor of radiation-induced neurocognitive decline.

OUTLINE: This is a multicenter study. Patients are stratified according to age in years (< 60 vs ≥ 60), extracranial disease controlled (≤ 3 months vs > 3 months), number of pre-operative brain metastases (1 vs 2-4), histology (lung vs radioresistant [brain metastases from a sarcoma, melanoma, or renal cell carcinoma histology] vs other), and resection cavity maximal diameter (≤ 3 cm vs > 3 cm). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole-brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks.
  • Arm II: Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure.

Serum, whole blood, and urine samples are collected at baseline and periodically during study for genetic markers, inflammatory markers, oxidative stress biomarkers, and hormone and growth factor studies by ELISA and other assays.

Patients complete the Functional Assessment of Cancer Therapy-Brain (FACT-BR), the activities of daily living (ADLs), the Fatigue/Uniscale Assessment, and the Linear Analog Self Assessment (LASA) quality-of-life questionnaires at baseline and periodically during study. Neurocognitive functions, such as memory, verbal fluency, visual attention, executive function, and delayed memory, are also assessed.

After completion of study therapy, patients are followed up periodically for 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions
  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site
  • Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site
  • Any unresected lesions must measure ≤ 3.0 cm in maximal extent on the contrasted MRI brain scan obtained ≤ 35 days prior to pre-registration
  • The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastases only surgical cavity size determines eligibility
  • Post-operative MRI confirmed zero, one, two or three unresected lesions
  • Each unresected lesion must measure ≤ 3.0 cm in maximal extent on the contrasted post-operative MRI brain scan
  • The pre-registration, post-operative, brain scan may be used for the randomization scan if obtained ≤ 28 days prior to randomization
  • Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior to randomization
  • Resection cavity must measure < 5.0 cm in maximal extent on the post-operative MRI (or CT) brain scan obtained ≤ 35 days prior to pre-registration
  • The pre-registration, post-operative brain scan may be used for the planning scan if obtained ≤ 28 days prior to randomization
  • Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior to randomization
  • It is permissible for the resection of a dominant brain metastasis to include a smaller "satellite" metastasis as long as the single resection cavity is less than the maximum size requirements
  • All standard tumor-staging procedures necessary to define baseline extracranial disease status completed ≤ 42 days prior to pre-registration
  • No primary germ cell tumor, small cell carcinoma, or lymphoma
  • No widespread definitive leptomeningeal metastasis
  • No brain metastasis that is located ≤ 5 mm of the optic chiasm or within the brainstem

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0, 1, or 2
  • Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system
  • Willing and able to complete neurocognitive examination without assistance
  • Willing and able to complete quality-of-life (QOL) questionnaires by themselves or with assistance
  • Willing to provide mandatory blood and urine samples for correlative research purposes
  • None of the following:
  • Pregnant or nursing
  • Men or women of childbearing potential who are unwilling to employ adequate contraception through out the study and for men for up to 3 months after completing treatment
  • Able to complete a MRI with contrast of the head
  • No known allergy to gadolinium

PRIOR CONCURRENT THERAPY:

  • No prior cranial radiotherapy
  • No planned cytotoxic chemotherapy during the stereotactic radiosurgery (SRS) or whole-brain radiotherapy (WBRT)
  • Concurrent hormonal agents, steroids, and/or anticonvulsants allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

National Cancer Institute

Paul D. BrownPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Phoenix
 Arizona Oncology - Deer Valley Center
 David G. Brachman Ph: 800-360-6371
  Scottsdale
 Mayo Clinic Scottsdale
 Nadia N Laack Ph: 507-538-7623
  Tucson
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Sun K Yi Ph: 520-626-9008
California
  Burlingame
 Peninsula Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Eric L Chang Ph: 323-865-0451
 Eric L Chang Ph: 323-865-0451
  Modesto
 Memorial Medical Center
 Jorge A Garcia-Young Ph: 209-572-7116
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Igor J Barani Ph: 877-827-3222
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Samantha A Seaward Ph: 626-564-3455
  Vallejo
 Sutter Solano Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
Colorado
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Neal B Goldberg Ph: 860-224-5660
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Sunjay A Shah Ph: 302-733-6227
 Sunjay A Shah Ph: 302-733-6227
Florida
  Hollywood
 Joe DiMaggio Children's Hospital
 Srinath Sundararaman Ph: 954-265-2234
  Jacksonville
 Mayo Clinic - Jacksonville
 Nadia N Laack Ph: 507-538-7623
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Fazilat Ishkanian Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Naren R Ramakrishna Ph: 321-841-7246
  Email: CancerClinicalTrials@orlandohealth.com
  Pembroke Pines
 Memorial Cancer Institute at Memorial Hospital West
 Srinath Sundararaman Ph: 954-265-2234
Georgia
  Columbus
 John B. Amos Cancer Center
 Douglas F. Ciuba Ph: 706-660-6404
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
  Ewa Beach
 Leeward Radiation Oncology
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
  Honolulu
 Cancer Research Center of Hawaii
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Hawaii Medical Center - East
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Kuakini Medical Center
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 OnCare Hawaii, Incorporated - Kuakini
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 OnCare Hawaii, Incorporated - Lusitana
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Queen's Cancer Institute at Queen's Medical Center
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
 Straub Clinic and Hospital, Incorporated
 William S. Loui Ph: 808-586-2979
  Email: dorothy@crch.hawaii.edu
Idaho
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Chicago
 University of Illinois Cancer Center
 Matthew Koshy Ph: 312-355-3046
  Peoria
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
Indiana
  South Bend
 Memorial Hospital of South Bend
 David A. Hornback Ph: 800-284-7370
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Parvesh Kumar Ph: 913-588-4709
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 John L Villano Ph: 859-257-3379
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Aaron C Spalding Ph: 502-629-2500
Maine
  Portland
 Maine Medical Center - Bramhall Campus
 Ian J Bristol Ph: 207-396-8090
  Email: wrighd@mmc.org
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Geoffrey A Neuner Ph: 443-849-3706
  Rockville
 Cancer Trials Support Unit
 Paul D. Brown
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Lynne P Taylor Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Lowell
 Lowell General Hospital
 Matthew S Katz Ph: 978-788-7084
  Email: ghincks@lowellgeneral.org
  Worcester
 Saint Vincent Hospital - Fallon Clinic
 William B Casey Ph: 508-363-7018
Michigan
  Detroit
 Wayne State University
 Harold E. Kim Ph: 313-576-9363
  Kalamazoo
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Rochester
 Mayo Clinic Cancer Center
 Nadia N Laack Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Paul D. Brown
Nebraska
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Andrew O Wahl Ph: 800-999-5465
New Hampshire
  Dover
 Seacoast Cancer Center at Wentworth - Douglass Hospital
 Arul Mahadevan Ph: 603-740-2150
  Exeter
 Center for Cancer Care at Exeter Hospital
 Gary Miller Proulx Ph: 800-439-3837
New Jersey
  Somerville
 Somerset Medical Center
 Joel K Braver Ph: 908-685-2481
New York
  Syracuse
 SUNY Upstate Medical University Hospital
 Seung Shin Hahn Ph: 315-464-5476
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Timothy M Zagar Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Greenville
 Leo W. Jenkins Cancer Center at ECU Medical School
 Clinton H Leinweber Ph: 252-744-2391
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 James J Urbanic Ph: 336-713-6771
North Dakota
  Bismarck
 Bismarck Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Cleveland
 Case Comprehensive Cancer Center
 Min Yao Ph: 800-641-2422
 Cleveland Clinic Taussig Cancer Center
 Samuel T Chao Ph: 866-223-8100
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Andrew Y Kee Ph: 507-538-7623
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Wayne H Pinover Ph: 215-481-2402
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
  Philadelphia
 Frankford Hospital Cancer Center - Torresdale Campus
 Voichita Bar Ad Ph: 215-955-6084
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Tennessee
  Knoxville
 Thompson Cancer Survival Center
 Joseph Thurmond Meyer Ph: 865-541-1812
Utah
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 R. Jeffrey Lee Ph: 801-507-3950
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Dennis C. Shrieve Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
Wisconsin
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
  Marshfield
 Marshfield Clinic - Marshfield Center
 Benjamin E. Lawler Ph: 715-389-4457
 Saint Joseph's Hospital
 Benjamin E. Lawler Ph: 715-389-4457
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Joseph A Bovi Ph: 414-805-4380
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Mitchell H. Pincus Ph: 800-252-2990
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Wingate F. Clapper Ph: 262-928-7632
Canada
Nova Scotia
  Halifax
 Nova Scotia Cancer Centre
 Liam A Mulroy Ph: 902-473-6000
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Anthony C Whitton Ph: 905-387-9495
  Toronto
 Princess Margaret Hospital
 Normand J Laperriere Ph: 416-946-4501
  Email: clinical.trials@uhn.on.ca
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 David Roberge Ph: 514-890-8000ext23611
  Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca
  Quebec City
 Centre Hospitalier Universitaire de Quebec
 Melanie Gaudreault Ph: 418-525-4444
  Sherbrooke
 CHUS-Hopital Fleurimont
 Laurence Masson-Cote Ph: 819-820-6480
  Email: crcinformation.chus@ssss.gouv.qc.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01372774
ClinicalTrials.gov processed this data on September 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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