Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01372774 : Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Pre-registration Inclusion Criteria:

1. Number of Brain Metastases - Four or fewer brain metastases (as defined on the
pre-operative MRI or CT brain scan) and status post resection of one of the lesions.

2. Non-CNS Primary Site - Pathology from the resected brain metastasis must be
consistent with a non-central nervous system primary site. Note: 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.

3. Size of Metastases - Any unresected lesions must measure < 3.0 cm in maximal extent
on the contrasted MRI or CT brain scan obtained ? 35 days prior to pre-registration.
The unresected lesions will be treated with SRS as outlined in the treatment section
of the protocol. Note: The metastases size restriction does not apply to the resected
brain metastasis; with resected brain metastases only surgical cavity size determines
eligibility.

4. Size of Resection Cavity - 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.

Note: 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.

5. Tumor Staging Procedures - All standard tumor-staging procedures necessary to define
baseline extra cranial disease status completed ?42 days prior to pre-registration.

6. Treatment with Gamma Knife or Radiosurgery - Able to be treated with either a gamma
knife or a linear accelerator-based radiosurgery system.

7. Age ? 18 years

8. Neurocognitive Testing - Willing and able to complete neurocognitive testing without
assistance from family and companions. Note: Because neurocognitive testing is one of
the primary goals of this study, patients must be able to utilize English language
booklets (and/or French booklets if enrolled in Canada).

9. Quality of Life (QOL) Questionnaires - Willing and able to complete QOL by themselves
or with assistance

10. ECOG Performance Status - ECOG Performance Status (PS) 0, 1, or 2.

11. SRS Credentialed by IROC Houston Quality Assurance - The site's SRS facility is IROC
Houston Quality Assurance approved.

12. Neurocognitive Testing Credentialing - The site study team member performing
neurocognitive testing of patients must have credentialing confirming completion of
the neurocognitive testing training of the protocol.

13. Written Informed Consent - Provide written informed consent

14. Mandatory Samples for Correlative Tests - Willing to provide mandatory blood and
urine samples for correlative research purposes.

Pre-registration Exclusion Criteria:

1. Pregnancy, Nursing and Contraception - pregnant women, nursing women and men or women
of childbearing potential who are unwilling to employ adequate contraception
throughout the study and for men for up to 3 months after completing treatment.

2. Prior Cranial Radiation Therapy

3. MRI or CT Scans - Inability to complete a MRI or CT scan with contrast of the head.

4. Gadolinium Allergy - Known allergy to gadolinium.

5. Cytotoxic Chemotherapy - Planned cytotoxic chemotherapy during the SRS or WBRT.

6. Other Tumor Types - Primary germ cell tumor, small cell carcinoma, or lymphoma

7. Leptomeningeal Metastasis - Widespread definitive leptomeningeal metastasis

8. Location of Brain Metastasis - A brain metastasis that is located ? 5 mm of the optic
chiasm or within the brainstem.

Randomization Inclusion Criteria:

1. Number of Unresected Lesions - Post-operative MRI or CT scan confirmed zero, one, two
or three unresected lesions.

1.1 Each unresected lesion must measure ? 3.0 cm in maximal extent on the contrasted
post-operative MRI or CT brain scan.

1.2 Note: The pre-registration, post-operative, brain scan may be used for the
randomization scan if obtained ? 28 days prior to randomization.

1.3 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.

2. Size of Resection Cavity - Post-operative MRI or CT scan confirms resection cavity
measures < 5.0 cm in maximal extent.

2.1 Note: The pre-registration, post-operative brain scan may be used for the
randomization scan if obtained ? 28 days prior to randomization.

2.2 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.

3. Urine or Serum Pregnancy Test - Negative urine or serum pregnancy test done ? 7 days
prior to randomization, for women of child bearing potential only.

Randomization Exclusion Criteria: none
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01372774      |      Link to official Clinicaltrials.gov listing
Locations
Burlingame, California
Facility: Mills - Peninsula Hospitals
Investigator:
Contact: Milana Dolezal, M.D. Phone: 510-204-3428
Email not avaialable

Los Angeles, California
Facility: Los Angeles County-USC Medical Center
Investigator:
Contact: Eric Chang, M.D. Phone: 323-865-3072
Email not avaialable

Los Angeles, California
Facility: USC / Norris Comprehensive Cancer Center
Investigator:
Contact: Eric Chang, MD Phone: 323-865-3072
Email not avaialable

Newark, Delaware
Facility: Christiana Care Health System-Christiana Hospital
Investigator:
Contact: Sunjay Shah, MD Phone: 302-623-4800
Email not avaialable

Miami Beach, Florida
Facility: Mount Sinai Medical Center
Investigator:
Contact: Michael Schwartz, MD Phone: 305-535-3310
Email not avaialable

Columbus, Georgia
Facility: John B Amos Cancer Center
Investigator:
Contact: Douglas Ciuba, M.D. Phone: 706-571-1050
Email not avaialable

Evanston, Illinois
Facility: NorthShore University HealthSystem-Evanston Hospital
Investigator:
Contact: Ryan Merrell, M.D. Phone: 847-570-2570
Email not avaialable

South Bend, Indiana
Facility: Memorial Hospital of South Bend
Investigator:
Contact: David Hornback, MD Phone: 574-647-7461
Email not avaialable

Lowell, Massachusetts
Facility: Lowell General Hospital
Investigator:
Contact: Matthew Katz, M.D. Phone: 978-937-6650
Email not avaialable

Worcester, Massachusetts
Facility: Saint Vincent Hospital/Reliant Medical Group
Investigator:
Contact: William Casey, M.D. Phone: 508-363-7100
Email not avaialable

Kalamazoo, Michigan
Facility: West Michigan Cancer Center
Investigator:
Contact: Sunil Nagpal, MD Phone: 269-382-2500
Email not avaialable

Bemidji, Minnesota
Facility: Sanford Clinic North-Bemidji
Investigator:
Contact: Preston Steen, M.D. Phone: 701-234-6161
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic Cancer Center
Investigator:
Contact: Nadia Laack, MD Phone: 507-284-4561
Email not avaialable

Saint Paul, Minnesota
Facility: Regions Hospital
Investigator:
Contact: Patrick Flynn, M.D. Phone: 952-993-1517
Email not avaialable

Saint Paul, Minnesota
Facility: United Hospital
Investigator:
Contact: Patrick J. Flynn, MD Phone: 612-884-6300
Email not avaialable

Omaha, Nebraska
Facility: University of Nebraska Medical Center
Investigator:
Contact: Andrew Wahl, M.D. Phone: 402-552-3844
Email not avaialable

Dover, New Hampshire
Facility: Wentworth-Douglass Hospital
Investigator:
Contact: Arul Mahadevan, MD Phone: 603-742-8787
Email not avaialable

Somerville, New Jersey
Facility: Somerset Medical Center
Investigator:
Contact: James Chimenti, M.D. Phone: 732-302-1720
Email not avaialable

Syracuse, New York
Facility: State University of New York Upstate Medical University
Investigator:
Contact: Seung Hahn, MD Phone: 315-464-5276
Email not avaialable

Chapel Hill, North Carolina
Facility: University of North Carolina at Chapel Hill
Investigator:
Contact: Timothy Zagar, MD Phone: 919-966-0400
Email not avaialable

Charlotte, North Carolina
Facility: Novant Health Presbyterian Medical Center
Investigator:
Contact: Justin Favaro, MD Phone: 704-342-1900
Email not avaialable

Bismarck, North Dakota
Facility: Sanford Bismarck Medical Center
Investigator:
Contact: Preston Steen, M.D. Phone: 701-234-6161
Email not avaialable

Fargo, North Dakota
Facility: Sanford Clinic North-Fargo
Investigator:
Contact: Preston Steen, M.D. Phone: 701-234-6161
Email not avaialable

Fargo, North Dakota
Facility: Sanford Roger Maris Cancer Center
Investigator:
Contact: Preston Steen, M.D. Phone: 701-234-6161
Email not avaialable

Akron, Ohio
Facility: Summa Akron City Hospital/Cooper Cancer Center
Investigator:
Contact: Jennifer Payne, MD Phone: 330-376-1043
Email not avaialable

Cleveland, Ohio
Facility: Case Western Reserve University
Investigator:
Contact: Min Yao, MD Phone: 216-844-2536
Email not avaialable

Portland, Oregon
Facility: Legacy Good Samaritan Hospital and Medical Center
Investigator:
Contact: Andrew Kee, MD Phone: 503-413-4161
Email not avaialable

Abington, Pennsylvania
Facility: Abington Memorial Hospital
Investigator:
Contact: Wayne Pinover, MD Phone: 215-481-2800
Email not avaialable

Bethlehem, Pennsylvania
Facility: Saint Luke's University Hospital-Bethlehem Campus
Investigator:
Contact: Deb Nimisha, M.D. Phone: 484-503-4400
Email not avaialable

Danville, Pennsylvania
Facility: Geisinger Medical Center
Investigator:
Contact: Thomas Gergel, MD Phone: 570-271-6304
Email not avaialable

Philadelphia, Pennsylvania
Facility: Aria Health-Torresdale Campus
Investigator:
Contact: Voichita Bar Ad, M.D. Phone: 215-955-0284
Email not avaialable

Sioux Falls, South Dakota
Facility: Sanford Cancer Center Oncology Clinic
Investigator:
Contact: Preston Steen, M.D. Phone: 701-234-6161
Email not avaialable

Sioux Falls, South Dakota
Facility: Sanford USD Medical Center - Sioux Falls
Investigator:
Contact: Preston Steen, M.D. Phone: 701-234-6161
Email not avaialable

Knoxville, Tennessee
Facility: Thompson Cancer Survival Center
Investigator:
Contact: Joseph Meyer, MD
Email not avaialable

Galveston, Texas
Facility: University of Texas Medical Branch
Investigator:
Contact: Todd Swanson, M.D. Phone: 409-772-7186
Email not avaialable

Green Bay, Wisconsin
Facility: Saint Vincent Hospital
Investigator:
Contact: Anthony Jaslowski, MD Phone: 920-884-3135
Email not avaialable

Milwaukee, Wisconsin
Facility: Froedtert and the Medical College of Wisconsin
Investigator:
Contact: Joseph Bovi, M.D. Phone: 414-805-4474
Email not avaialable




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