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.]

NCT02753790 : Whole Brain Radiation Using IMRT for Patients With Brain Metastases
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Pathologically proven diagnosis of a non-hematopoietic malignancy other than small
cell lung cancer and germ cell malignancy within 5 years of registration. Patients
with metastasis of unknown primary tumor are permitted.

- History/physical examination within 30 days prior to registration.

- Age = 18 years

- Karnofsky performance status = 70

- Ability to understand and the willingness to sign a written informed consent document.

- Women of child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry, for the duration of
study participation, and for 90 days following completion of therapy. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately.

- Women of childbearing potential must have a negative qualitative serum pregnancy test
= 2 weeks prior to study entry. A female of child-bearing potential is any woman
(regardless of sexual orientation, having undergone a tubal ligation, or remaining
celibate by choice) who meets the following criteria: 1) Has not undergone a
hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal
for at least 12 consecutive months (i.e., has had menses at any time in the preceding
12 consecutive months).

- More than one brain metastasis (qualifying measurable brain lesions are any contrast
enhancing metastases identifiable by the physician).

- Patients who have undergone a resection for brain metastases will be eligible for
participation if they have any residual metastases present on post operative MRI of
the brain.

Exclusion Criteria:

- Patients with leptomeningeal metastases

- Plan for chemotherapy or targeted therapies during whole brain radiation or within 1
week of completing radiation therapy

- Contraindication to Magnetic Resonance (MR) imaging

- Serum creatinine > 1.4 mg/dl = 30 days prior to study entry

- Prior radiation therapy to the brain besides radiosurgery

- Severe active comorbidities which would make the patient an unacceptable candidate for
this clinical trial per physician discretion

- Patients with brain metastases involving the brainstem or chiasm

- Non English speaking patients
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02753790      |      Link to official Clinicaltrials.gov listing
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