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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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).
  • - Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.
  • - The largest brain metastasis must measure <2.5 cm in maximal diameter.
  • - Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.
  • - Patient must be > 18 years of age.
  • - 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.
  • - ECOG performance status 0, 1, or 2.
  • - Creatinine clearance must be ≥ 30 ml/min within 28 days prior to registration.
  • - The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.
  • - 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.
  • - 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.
  • - A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.
  • - 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.
  • - In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.
  • - Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion Criteria:

  • - Pregnant or nursing women.
  • - Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • - Inability to complete a brain MRI.
  • - Known allergy to gadolinium.
  • - Prior cranial radiation therapy.
  • - Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.
  • - Primary germ cell tumour, small cell carcinoma, or lymphoma.
  • - 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.
  • - A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.
  • - Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).
  • - 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.
  • - Prior allergic reaction to memantine.
  • - Current alcohol or drug abuse.
  • - Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.
  • - Diagnosis of chronic liver disease/cirrhosis of the liver (e.g. Child-Pugh class B or C).
- Patients with architectural distortion of lateral ventricular systems, which, in the opinion of the local investigator, makes hippocampal delineation challenging

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03550391
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Canadian Cancer Trials Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David RobergeMichael ChanVina Gondi
Principal Investigator Affiliation CHUM-Centre Hospitalier de l'Universite de MontrealWake Forest School of Medicine, Winston-Salem, NCNorthwestern Medicine Cancer Center, Warrenville IL
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases
Additional Details

The purpose of this research study is to compare the effects (good or bad) of receiving stereotactic radiosurgery (SRS) versus receiving hippocampal-avoidant whole brain radiotherapy (HA-WBRT) plus a drug called memantine, on brain metastases. Receiving SRS could control cancer that has spread to the brain. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the stereotactic radiosurgery (SRS) helps to either slow the growth of cancer or stop it from coming back, compared to the usual approach. Doctors will also look to see if this new approach increases the life span of patients with this type of cancer, and if it helps with quality of life and cancer related symptoms. The usual approach for patients who are not in a study is treatment with whole brain radiation therapy alone (WBRT).

Arms & Interventions

Arms

Experimental: Hippocampal-avoidant (HA-WBRT) plus Memantine

WBRT 30Gy in 10 fractions + memantine

Experimental: Stereotactic Radiosurgery (SRS)

SRS 18-20 or 22Gy in single fraction

Interventions

Drug: - Memantine

20 mg (10 mg divided twice daily). Dose will be escalated by 5 mg per week. Memantine should start at 5 mg, and then increased in 5 mg increments at the following schedule, depending on the patient's response and tolerance:

Radiation: - Hippocampal-avoidant (HA-WBRT) Radiotherapy

30Gy in 10 fractions

Procedure: - Stereotactic Radiosurgery (SRS)

18-20 or 22 Gy in single fraction

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson, Arizona

Status

Suspended

Address

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704

Tucson, Arizona

Status

Suspended

Address

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719

City of Hope Corona, Corona, California

Status

Recruiting

Address

City of Hope Corona

Corona, California, 92879

Site Contact

Site Public Contact

[email protected]

800-826-4673

City of Hope Comprehensive Cancer Center, Duarte, California

Status

Recruiting

Address

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Site Contact

Site Public Contact

[email protected]

800-826-4673

City of Hope at Irvine Lennar, Irvine, California

Status

Recruiting

Address

City of Hope at Irvine Lennar

Irvine, California, 92618

Site Contact

Site Public Contact

[email protected]

877-467-3411

UC San Diego Moores Cancer Center, La Jolla, California

Status

Recruiting

Address

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Site Contact

Site Public Contact

[email protected]

858-822-5354

City of Hope Antelope Valley, Lancaster, California

Status

Recruiting

Address

City of Hope Antelope Valley

Lancaster, California, 93534

Site Contact

Site Public Contact

[email protected]

800-826-4673

Orange, California

Status

Suspended

Address

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

Rancho Cordova, California

Status

Active, not recruiting

Address

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670

Rohnert Park Cancer Center, Rohnert Park, California

Status

Active, not recruiting

Address

Rohnert Park Cancer Center

Rohnert Park, California, 94928

Roseville, California

Status

Active, not recruiting

Address

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678

South Sacramento Cancer Center, Sacramento, California

Status

Active, not recruiting

Address

South Sacramento Cancer Center

Sacramento, California, 95823

Santa Clara, California

Status

Active, not recruiting

Address

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051

City of Hope South Pasadena, South Pasadena, California

Status

Recruiting

Address

City of Hope South Pasadena

South Pasadena, California, 91030

Site Contact

Site Public Contact

[email protected]

800-826-4673

South San Francisco, California

Status

Active, not recruiting

Address

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080

City of Hope South Bay, Torrance, California

Status

Recruiting

Address

City of Hope South Bay

Torrance, California, 90503

Site Contact

Site Public Contact

[email protected]

877-467-3411

City of Hope Upland, Upland, California

Status

Recruiting

Address

City of Hope Upland

Upland, California, 91786

Site Contact

Site Public Contact

[email protected]

800-826-4673

Boca Raton Regional Hospital, Boca Raton, Florida

Status

Active, not recruiting

Address

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

Coral Gables, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

Site Contact

Site Public Contact

[email protected]

305-243-2647

Deerfield Beach, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

Site Contact

Site Public Contact

[email protected]

305-243-2647

Hollywood, Florida

Status

Recruiting

Address

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

Site Contact

Site Public Contact

[email protected]

954-265-1847

Mayo Clinic in Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Site Contact

Site Public Contact

[email protected]

855-776-0015

Miami, Florida

Status

Recruiting

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Site Contact

Site Public Contact

[email protected]

305-243-2647

Memorial Hospital West, Pembroke Pines, Florida

Status

Recruiting

Address

Memorial Hospital West

Pembroke Pines, Florida, 33028

Site Contact

Site Public Contact

[email protected]

954-265-4325

Plantation, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

Site Contact

Site Public Contact

[email protected]

305-243-2647

Moffitt Cancer Center, Tampa, Florida

Status

Active, not recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Piedmont Hospital, Atlanta, Georgia

Status

Active, not recruiting

Address

Piedmont Hospital

Atlanta, Georgia, 30309

Atlanta, Georgia

Status

Suspended

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Emory Saint Joseph's Hospital, Atlanta, Georgia

Status

Suspended

Address

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho

Status

Suspended

Address

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

Northwestern University, Chicago, Illinois

Status

Active, not recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Decatur Memorial Hospital, Decatur, Illinois

Status

Recruiting

Address

Decatur Memorial Hospital

Decatur, Illinois, 62526

Site Contact

Site Public Contact

[email protected]

217-876-4762

Loyola University Medical Center, Maywood, Illinois

Status

Recruiting

Address

Loyola University Medical Center

Maywood, Illinois, 60153

Site Contact

Site Public Contact

[email protected]

708-226-4357

Methodist Medical Center of Illinois, Peoria, Illinois

Status

Recruiting

Address

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

Site Contact

Site Public Contact

[email protected]

309-243-3605

OSF Saint Francis Medical Center, Peoria, Illinois

Status

Recruiting

Address

OSF Saint Francis Medical Center

Peoria, Illinois, 61637

Site Contact

Site Public Contact

[email protected]

309-243-3605

Carle Cancer Center, Urbana, Illinois

Status

Recruiting

Address

Carle Cancer Center

Urbana, Illinois, 61801

Site Contact

Site Public Contact

[email protected]

800-446-5532

Warrenville, Illinois

Status

Active, not recruiting

Address

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

Community Cancer Center North, Indianapolis, Indiana

Status

Active, not recruiting

Address

Community Cancer Center North

Indianapolis, Indiana, 46256

Iowa Methodist Medical Center, Des Moines, Iowa

Status

Recruiting

Address

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

Site Contact

Site Public Contact

[email protected]

515-241-6727

Anne Arundel Medical Center, Annapolis, Maryland

Status

Active, not recruiting

Address

Anne Arundel Medical Center

Annapolis, Maryland, 21401

Tufts Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Site Contact

Site Public Contact

[email protected]

617-636-5000

Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Site Contact

Site Public Contact

[email protected]

800-865-1125

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Site Public Contact

[email protected]

855-776-0015

Regions Hospital, Saint Paul, Minnesota

Status

Recruiting

Address

Regions Hospital

Saint Paul, Minnesota, 55101

Site Contact

Site Public Contact

[email protected]

952-993-1517

Saint Francis Medical Center, Cape Girardeau, Missouri

Status

Recruiting

Address

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

Site Contact

Site Public Contact

[email protected]

573-334-2230

Creve Coeur, Missouri

Status

Recruiting

Address

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

Site Contact

Site Public Contact

[email protected]

800-600-3606

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Site Public Contact

[email protected]

800-600-3606

Siteman Cancer Center-South County, Saint Louis, Missouri

Status

Recruiting

Address

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

Site Contact

Site Public Contact

[email protected]

800-600-3606

Missouri Baptist Medical Center, Saint Louis, Missouri

Status

Recruiting

Address

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

Site Contact

Site Public Contact

[email protected]

314-996-5569

Saint Peters, Missouri

Status

Recruiting

Address

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

Site Contact

Site Public Contact

[email protected]

800-600-3606

Billings Clinic Cancer Center, Billings, Montana

Status

Recruiting

Address

Billings Clinic Cancer Center

Billings, Montana, 59101

Site Contact

Site Public Contact

[email protected]

800-996-2663

Great Falls, Montana

Status

Recruiting

Address

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405

Site Contact

Site Public Contact

[email protected]

406-969-6060

Lebanon, New Hampshire

Status

Active, not recruiting

Address

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

AtlantiCare Surgery Center, Egg Harbor Township, New Jersey

Status

Recruiting

Address

AtlantiCare Surgery Center

Egg Harbor Township, New Jersey, 08234

Site Contact

Site Public Contact

[email protected]

609-748-7200

Syracuse, New York

Status

Recruiting

Address

State University of New York Upstate Medical University

Syracuse, New York, 13210

Site Contact

Site Public Contact

[email protected]

315-464-5476

Syracuse, New York

Status

Suspended

Address

SUNY Upstate Medical Center-Community Campus

Syracuse, New York, 13215

Mission Hospital, Asheville, North Carolina

Status

Active, not recruiting

Address

Mission Hospital

Asheville, North Carolina, 28801

Cone Health Cancer Center, Greensboro, North Carolina

Status

Recruiting

Address

Cone Health Cancer Center

Greensboro, North Carolina, 27403

Site Contact

Site Public Contact

[email protected]

336-832-0836

East Carolina University, Greenville, North Carolina

Status

Recruiting

Address

East Carolina University

Greenville, North Carolina, 27834

Site Contact

Site Public Contact

[email protected]

252-744-1015

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Site Contact

Site Public Contact

[email protected]

336-713-6771

Sanford Bismarck Medical Center, Bismarck, North Dakota

Status

Recruiting

Address

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

Site Contact

Site Public Contact

[email protected]

701-323-5760

Oklahoma City, Oklahoma

Status

Active, not recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Portland, Oregon

Status

Recruiting

Address

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210

Site Contact

Site Public Contact

[email protected]

800-220-4937

Geisinger Medical Center, Danville, Pennsylvania

Status

Recruiting

Address

Geisinger Medical Center

Danville, Pennsylvania, 17822

Site Contact

Site Public Contact

[email protected]

570-271-5251

Fox Chase Cancer Center Buckingham, Furlong, Pennsylvania

Status

Active, not recruiting

Address

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, 18925

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Status

Active, not recruiting

Address

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Wilkes-Barre, Pennsylvania

Status

Recruiting

Address

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

Site Contact

Site Public Contact

[email protected]

570-271-5251

Self Regional Healthcare, Greenwood, South Carolina

Status

Active, not recruiting

Address

Self Regional Healthcare

Greenwood, South Carolina, 29646

Salt Lake City, Utah

Status

Suspended

Address

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont

Status

Active, not recruiting

Address

Norris Cotton Cancer Center-North

Saint Johnsbury, Vermont, 05819

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Site Public Contact

[email protected]

414-805-3666

International Sites

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Status

Recruiting

Address

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2

Site Contact

Site Public Contact

[email protected]

403-521-3433

Cross Cancer Institute, Edmonton, Alberta, Canada

Status

Recruiting

Address

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2

Site Contact

Site Public Contact

[email protected]

780-432-8500

BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada

Status

Recruiting

Address

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6

Site Contact

Site Public Contact

[email protected]

888-939-3333

Halifax, Nova Scotia, Canada

Status

Recruiting

Address

QEII Health Sciences Centre/Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9

Site Contact

Site Public Contact

[email protected]

902-473-6000

Hamilton, Ontario, Canada

Status

Recruiting

Address

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2

Site Contact

Site Public Contact

[email protected]

905-387-9495

London Regional Cancer Program, London, Ontario, Canada

Status

Suspended

Address

London Regional Cancer Program

London, Ontario, N6A 4L6

Toronto, Ontario, Canada

Status

Recruiting

Address

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9

Site Contact

Site Public Contact

[email protected]

416-946-4501

CSSS Champlain-Charles Le Moyne, Greenfield Park, Quebec, Canada

Status

Suspended

Address

CSSS Champlain-Charles Le Moyne

Greenfield Park, Quebec, J4V 2H1

Montreal, Quebec, Canada

Status

Recruiting

Address

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4

Site Contact

Site Public Contact

[email protected]

514-890-8000 #12725

Montreal, Quebec, Canada

Status

Recruiting

Address

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9

Site Contact

Site Public Contact

[email protected]

514-934-1934 #48354

Jewish General Hospital, Montreal, Quebec, Canada

Status

Suspended

Address

Jewish General Hospital

Montreal, Quebec, H3T 1E2

Quebec City, Quebec, Canada

Status

Recruiting

Address

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

Quebec City, Quebec, G1R 2J6

Site Contact

Site Public Contact

[email protected]

613-533-6430

Sherbrooke, Quebec, Canada

Status

Suspended

Address

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4