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

April 11, 2024 updated by: Canadian Cancer Trials Group

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 403-521-3433
        • Principal Investigator:
          • Muhammad S. Faruqi
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 780-432-8500
        • Principal Investigator:
          • Samir I. Patel
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BCCA-Vancouver Cancer Centre
        • Principal Investigator:
          • Alan M. Nichol
        • Contact:
          • Site Public Contact
          • Phone Number: 888-939-3333
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre/Nova Scotia Health Authority
        • Contact:
          • Site Public Contact
          • Phone Number: 902-473-6000
        • Principal Investigator:
          • Liam A. Mulroy
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre at Hamilton Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 905-387-9495
        • Principal Investigator:
          • Jeffrey N. Greenspoon
      • London, Ontario, Canada, N6A 4L6
        • Suspended
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network-Princess Margaret Hospital
        • Principal Investigator:
          • David B. Shultz
        • Contact:
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Suspended
        • CSSS Champlain-Charles Le Moyne
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • CHUM - Centre Hospitalier de l'Universite de Montreal
        • Contact:
        • Principal Investigator:
          • David Roberge
      • Montreal, Quebec, Canada, H3H 2R9
        • Recruiting
        • The Research Institute of the McGill University Health Centre (MUHC)
        • Contact:
        • Principal Investigator:
          • Valerie Panet-Raymond
      • Montreal, Quebec, Canada, H3T 1E2
        • Suspended
        • Jewish General Hospital
      • Quebec City, Quebec, Canada, G1R 2J6
        • Recruiting
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
        • Contact:
        • Principal Investigator:
          • Isabelle Thibault
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Suspended
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Principal Investigator:
          • Baldassarre Stea
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • University of Arizona Cancer Center-Orange Grove Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 520-694-8900
        • Principal Investigator:
          • Baldassarre Stea
    • California
      • Corona, California, United States, 92879
        • Recruiting
        • City of Hope Corona
        • Contact:
        • Principal Investigator:
          • Sean Szeja
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Sean Szeja
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope At Irvine Lennar
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Sean Szeja
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Jona A. Hattangadi-Gluth
        • Contact:
      • Lancaster, California, United States, 93534
        • Recruiting
        • City of Hope Antelope Valley
        • Contact:
        • Principal Investigator:
          • Sean Szeja
      • Orange, California, United States, 92868
        • Suspended
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Rancho Cordova, California, United States, 95670
        • Active, not recruiting
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Rohnert Park, California, United States, 94928
        • Active, not recruiting
        • Rohnert Park Cancer Center
      • Roseville, California, United States, 95678
        • Active, not recruiting
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Sacramento, California, United States, 95823
        • Active, not recruiting
        • South Sacramento Cancer Center
      • Santa Clara, California, United States, 95051
        • Active, not recruiting
        • Kaiser Permanente Medical Center - Santa Clara
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Contact:
        • Principal Investigator:
          • Sean Szeja
      • South San Francisco, California, United States, 94080
        • Active, not recruiting
        • Kaiser Permanente Cancer Treatment Center
      • Torrance, California, United States, 90503
        • Recruiting
        • City of Hope South Bay
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Sean Szeja
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope Upland
        • Contact:
        • Principal Investigator:
          • Sean Szeja
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Active, not recruiting
        • Boca Raton Regional Hospital
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Eric A. Mellon
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Eric A. Mellon
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
        • Principal Investigator:
          • Michael J. Burdick
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Daniel Trifiletti
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Eric A. Mellon
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Hospital West
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-4325
        • Principal Investigator:
          • Michael J. Burdick
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Eric A. Mellon
      • Tampa, Florida, United States, 33612
        • Active, not recruiting
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Suspended
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30309
        • Active, not recruiting
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30322
        • Suspended
        • Emory University Hospital/Winship Cancer Institute
    • Idaho
      • Boise, Idaho, United States, 83706
        • Suspended
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Active, not recruiting
        • Northwestern University
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Anupama Chundury
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Warrenville, Illinois, United States, 60555
        • Active, not recruiting
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Active, not recruiting
        • Community Cancer Center North
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Active, not recruiting
        • Anne Arundel Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Michelle M. Kim
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Daniel Trifiletti
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
      • Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Jiayi Huang
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Active, not recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Recruiting
        • AtlantiCare Surgery Center
        • Principal Investigator:
          • James C. Wurzer
        • Contact:
          • Site Public Contact
          • Phone Number: 609-748-7200
    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Michael D. Mix
      • Syracuse, New York, United States, 13215
        • Suspended
        • SUNY Upstate Medical Center-Community Campus
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Active, not recruiting
        • Mission Hospital
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Cone Health Cancer Center
        • Principal Investigator:
          • Sarah E. Squire
        • Contact:
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Jasmin Jo
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Michael D. Chan
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Active, not recruiting
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-220-4937
          • Email: cancer@lhs.org
        • Principal Investigator:
          • Andrew Y. Kee
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Furlong, Pennsylvania, United States, 18925
        • Active, not recruiting
        • Fox Chase Cancer Center Buckingham
      • Philadelphia, Pennsylvania, United States, 19111
        • Active, not recruiting
        • Fox Chase Cancer Center
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
    • South Carolina
      • Greenwood, South Carolina, United States, 29646
        • Active, not recruiting
        • Self Regional Healthcare
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Suspended
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Active, not recruiting
        • Norris Cotton Cancer Center-North
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Michael W. Straza

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hippocampal-avoidant (HA-WBRT) plus Memantine
WBRT 30Gy in 10 fractions + memantine
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
Experimental: Stereotactic Radiosurgery (SRS)
SRS 18-20 or 22Gy in single fraction
Procedure: Stereotactic Radiosurgery (SRS)
18-20 or 22 Gy in single fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 4.5 years
To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive HA-WBRT + memantine
4.5 years
Neurocognitive progression-free survival
Time Frame: 4.5 years
To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive HA-WBRT + memantine
4.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive HA-WBRT + memantine
Time Frame: 4.5 years
4.5 years
Difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive HA-WBRT + memantine
Time Frame: 4.5 years
4.5 years
Number of salvage procedures following SRS in comparison to HA-WBRT + memantine
Time Frame: 4.5 years
4.5 years
Neurocognitive progression-free survival in patients who receive SRS compared to HA-WBRT + memantine
Time Frame: 4.5 years
measured from date the patient is randomized to date at which there is a drop of at least 1.5 standard deviations from baseline in two of the six neurocognitive tests (all tests are standardized based on published norms)
4.5 years
Tabulate and descriptively compare the post-treatment adverse events associated with the interventions.
Time Frame: 4.5 years
4.5 years
Time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to HA-WBRT + memantine
Time Frame: 4.5 years
4.5 years
Prospectively validate a predictive nomogram for distant brain failure in patients who receive SRS
Time Frame: 4.5 years
a predictive nomogram as a clinically useful tool to determine the likelihood of distant brain failure (DBF) at different time points after radiosurgery
4.5 years
Compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive HA-WBRT + memantine.
Time Frame: 4.5 years
Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding)
4.5 years
Quality of life, as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) with brain cancer module (BN20)
Time Frame: 4.5 years
4.5 years
Quality of life assessed by ECOG performance status
Time Frame: 4.5 years
4.5 years
Quality of life, as assessed by EQ-5D-5L
Time Frame: 4.5 years
4.5 years
Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.
Time Frame: 4.5 years
4.5 years
Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes
Time Frame: 4.5 years
4.5 years
Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis
Time Frame: 4.5 years
4.5 years
Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes
Time Frame: 4.5 years
4.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

Alliance for Clinical Trials in Oncology
NRG Oncology

Investigators

  • Study Chair: David Roberge, CHUM-Centre Hospitalier de l'Universite de Montreal
  • Study Chair: Michael Chan, Wake Forest School of Medicine, Winston-Salem, NC
  • Study Chair: Vina Gondi, 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 Major Dates

Study Start (Actual)

November 22, 2018

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTG CE.7
  • NCI-2018-00395 (Other Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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