RECRUITING

Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

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Brain Metastases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain. Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms. Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.

Official Title

A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

Quick Facts

Study Start:2018-11-22
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03550391

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).
  2. * Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.
  3. * The largest brain metastasis must measure \<2.5 cm in maximal diameter.
  4. * Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.
  5. * Patient must be \> 18 years of age.
  6. * Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance.
  7. * ECOG performance status 0, 1, or 2.
  8. * Creatinine clearance must be ≥ 30 ml/min within 28 days prior to registration.
  9. * The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.
  10. * Facility is credentialed by IROC to perform SRS and HA-WBRT. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients. The treating centre must have completed IMRT credintialing of this specific IMRT systems to be used in study patients for the purposes of HA-WBRT.
  11. * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
  12. * A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.
  13. * Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  14. * In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.
  15. * Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
  1. * Pregnant or nursing women.
  2. * Men or women of childbearing potential who are unwilling to employ adequate contraception.
  3. * Inability to complete a brain MRI.
  4. * Known allergy to gadolinium.
  5. * Prior cranial radiation therapy.
  6. * Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.
  7. * Primary germ cell tumour, small cell carcinoma, or lymphoma.
  8. * Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.
  9. * A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.
  10. * Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).
  11. * More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm or smaller) performed within the past 14 days, or more than 10 metastases in the case of a non-volumetric MRI.
  12. * Prior allergic reaction to memantine.
  13. * Current alcohol or drug abuse.
  14. * Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.
  15. * Diagnosis of chronic liver disease/cirrhosis of the liver (e.g. Child-Pugh class B or C).
  16. * Patients with architectural distortion of lateral ventricular systems, which, in the opinion of the local investigator, makes hippocampal delineation challenging

Contacts and Locations

Study Contact

Chris O'Callaghan
CONTACT
613-533-6430
cocallaghan@ctg.queensu.ca

Principal Investigator

David Roberge
STUDY_CHAIR
CHUM-Centre Hospitalier de l'Universite de Montreal
Michael Chan
STUDY_CHAIR
Wake Forest School of Medicine, Winston-Salem, NC
Vina Gondi
STUDY_CHAIR
Northwestern Medicine Cancer Center, Warrenville IL

Study Locations (Sites)

University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
City of Hope Corona
Corona, California, 92879
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
City of Hope Antelope Valley
Lancaster, California, 93534
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670
United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928
United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
United States
South Sacramento Cancer Center
Sacramento, California, 95823
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
United States
City of Hope South Pasadena
South Pasadena, California, 91030
United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
United States
City of Hope South Bay
Torrance, California, 90503
United States
City of Hope Upland
Upland, California, 91786
United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
Memorial Hospital West
Pembroke Pines, Florida, 33028
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Piedmont Hospital
Atlanta, Georgia, 30309
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
United States
Northwestern University
Chicago, Illinois, 60611
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
Community Cancer Center North
Indianapolis, Indiana, 46256
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Siteman Cancer Center-South County
Saint Louis, Missouri, 63129
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, 63376
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
AtlantiCare Surgery Center
Egg Harbor Township, New Jersey, 08234
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, 13215
United States
Mission Hospital
Asheville, North Carolina, 28801
United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Self Regional Healthcare
Greenwood, South Carolina, 29646
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Canadian Cancer Trials Group

  • David Roberge, STUDY_CHAIR, CHUM-Centre Hospitalier de l'Universite de Montreal
  • Michael Chan, STUDY_CHAIR, Wake Forest School of Medicine, Winston-Salem, NC
  • Vina Gondi, STUDY_CHAIR, Northwestern Medicine Cancer Center, Warrenville IL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-22
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2018-11-22
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Brain Metastases