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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01372774
First received: June 11, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Cognitive/Functional Effects
Metastatic Cancer
Neurotoxicity
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
Radiation: whole-brain radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared With Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Neurocognitive progression at 6 months post-radiation in patients who received SRS compared to patients who received WBRT [ Time Frame: Up to 6 months post radiation ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 6 months post radiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local control of the surgical bed [ Time Frame: Up to 6 months post radiation ] [ Designated as safety issue: No ]
  • Time to CNS failure in these patients [ Time Frame: Up to 6 months post radiation ] [ Designated as safety issue: No ]
  • Quality-of-life at 6 months of these patients [ Time Frame: Up to 6 months post randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: July 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks.
Radiation: whole-brain radiation therapy
Undergo radiotherapy (RT)
Experimental: Arm II
Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure.
Radiation: stereotactic radiosurgery
Undergo RT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372774

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Nadia Laack, M.D.    507-284-4561      
United States, California
Mills - Peninsula Hospitals Recruiting
Burlingame, California, United States, 94010
Contact: Ari Baron, M.D.    415-923-3012      
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente    323-865-0451      
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Eric Chang, M.D.    323-865-3072      
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Eric Chang, M.D.    323-865-3072      
Memorial Medical Center Recruiting
Modesto, California, United States, 95355
Contact: Jorge Garcia-Young, M.D.    209-572-7237      
Kaiser Permanente-South San Francisco Recruiting
San Francisco, California, United States, 94080
Contact: Samantha Seaward, M.D.    408-851-8000      
United States, Colorado
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Broward Health North Recruiting
Deerfield Beach, Florida, United States, 33064
Contact: Marshal Lieberfarb    954-786-6747      
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Nadia Laack, M.D.    507-284-4561      
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Laurie E. Blach    305-674-2625      
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Naren R. Ramakrishna    407-648-3800      
United States, Georgia
John B Amos Cancer Center Recruiting
Columbus, Georgia, United States, 31904
Contact: Douglas Ciuba, M.D.    706-571-1050      
United States, Illinois
Evanston CCOP-NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Ryan Merrell, M.D.    847-570-2570      
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453-2699
Contact: Faisal S. Vali    708-684-8000      
United States, Indiana
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
United States, Iowa
Mercy Regional Cancer Center at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-398-6011      
United States, Kentucky
Louisville Oncology at Norton Cancer Institute - Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Clinical Trials Office - Louisville Oncology    502-629-2500      
United States, Maryland
MedStar Franklin Square Medical Center/Weinberg Cancer Institute Recruiting
Baltimore, Maryland, United States, 21237
Contact: David Perry, M.D.    410-682-6800      
United States, Massachusetts
Tufts Medical Center Cancer Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Lynne P. Taylor    617-636-6100      
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Matthew Katz, M.D.    978-937-6650      
Saint Vincent Hospital/Reliant Medical Group Recruiting
Worcester, Massachusetts, United States, 01608
Contact: William Casey, M.D.    508-363-7100      
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Harold Kim, M.D.    313-966-0556      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
United States, Minnesota
Sanford Clinic North-Bemidji Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston Steen, M.D.    701-234-6161      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
CentraCare Clinic - River Campus Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens    320-252-5131      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn, MD    612-884-6300      
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Patrick Flynn, M.D.    952-993-1517      
United States, Missouri
Cancer Institute of Cape Girardeau, LLC Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Tapan Roy, MD    573-334-2230      
Cape Radiation Oncology Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Tapan Roy    573-334-2230      
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Andrew Wahl, M.D.    402-552-3844      
United States, New Hampshire
Seacoast Cancer Center at Wentworth - Douglass Hospital Recruiting
Dover, New Hampshire, United States, 03820
Contact: Arul Mahadevan    603-742-8787      
Exeter Hospital Recruiting
Exeter, New Hampshire, United States, 03833
Contact: Gary Proulx, M.D.    603-580-7337      
United States, New Jersey
Somerset Medical Center Recruiting
Somerville, New Jersey, United States, 08876
Contact: James Chimenti, M.D.    732-302-1720      
United States, New York
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt    704-384-5369      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, North Dakota
Medcenter One Hospital Cancer Care Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: John T. Reynolds    701-323-5741      
Mid Dakota Clinic, PC Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Clinical Trials Office - Mid Dakota Clinic, PC    701-530-6950      
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Preston Steen, M.D.    701-234-6161      
Sanford Clinic North-Fargo Recruiting
Fargo, North Dakota, United States, 58102
Contact: Preston Steen, M.D.    701-234-6161      
Sanford Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston Steen, M.D.    701-234-6161      
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Mount Carmel St. Ann's Cancer Center Recruiting
Westerville, Ohio, United States, 43081
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Charles E. Stewart    918-494-2273      
Natalie W Bryant Cancer Center Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Charles Stewart, M.D.    918-494-1585      
United States, Oregon
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Recruiting
Portland, Oregon, United States, 97210
Contact: Clinical Trials Office - Legacy Good Samaritan Hospital & Com    503-413-1742      
Salem Hospital Regional Cancer Care Services Recruiting
Salem, Oregon, United States, 97309-5014
Contact: Clinical Trials Office - Salem Hospital Regional Cancer Care S    503-561-2618      
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M    215-481-2402      
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Suresh G. Nair, MD    610-402-0512      
Saint Luke's University Hospital-Bethlehem Campus Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Deb Nimisha, M.D.    484-503-4400      
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Aria Health-Torresdale Campus Recruiting
Philadelphia, Pennsylvania, United States, 19114
Contact: Voichita Bar Ad, M.D.    215-955-0284      
Frankford Hospital Cancer Center - Torresdale Campus Recruiting
Philadelphia, Pennsylvania, United States, 19114
Contact: Avnish Bhatia    215-612-4880      
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni    843-792-9321      
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Richard C. Tenglin    605-719-2360      
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Miroslaw Mazurczak, M.D.    605-328-8000      
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117
Contact: Miroslaw Mazurczak, M.D.    605-328-8000      
United States, Tennessee
Thompson Cancer Survival Center Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Clinical Trials Office - Thompson Cancer Survival Center    865-541-1812      
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Todd Swanson, M.D.    409-772-7186      
United States, Utah
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: Jeffrey Lee    713-792-7218      
Huntsman Cancer Institute at University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi    801-581-4477    clinical.trials@hci.utah.edu   
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center    800-782-1581 ext 94457      
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Benjamin E. Lawler    715-389-3133      
Community Memorial Hospital Recruiting
Menomonee Falls, Wisconsin, United States, 53051
Contact: Joseph Bovi, M.D.    414-805-4474      
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Joseph Bovi, M.D.    414-805-4474      
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic    414-649-5717      
Canada, Nova Scotia
Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V8
Contact: Liam A. Mulroy    902-473-6000      
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Anthony C. Whitton    905-387-9495      
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Normand J. Laperriere    416-946-2811      
Canada, Quebec
Hopital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: David Roberge    514-281-6000      
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Melanie Gaudreault    418-525-4444      
CHUS-Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Laurence Masson-Cote    819-346-1110      
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Paul D. Brown, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT01372774     History of Changes
Other Study ID Numbers: N107C, NCCTG-N107C, CDR0000701474, NCI-2011-02676
Study First Received: June 11, 2011
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
neurotoxicity
radiation toxicity
cognitive/functional effects
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neurotoxicity Syndromes
Radiation Injuries
Chemically-Induced Disorders
Neoplasms
Neoplastic Processes
Nervous System Diseases
Pathologic Processes
Poisoning
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014