Clinical Trial Details
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[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
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