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.]

NCT02672995 : Fractionated Stereotactic Radiosurgery With Concurrent Bevacizumab for Brain Metastases: A Phase I Dose-escalation Trial
PhasePhase 1
AgesMin: 20 Years Max: N/A
Eligibility
Inclusion criteria

To be eligible for inclusion, patients must fulfill the following criteria:

1. Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic
evidence of measurable brain metastases (1.5~3.5 cm).

2. The number of brain metastases receiving fractionated SRS: =3.

3. No evidence of leptomeningeal metastasis on gadolinium-enhanced MRI within 30 days
prior registration.

4. Age = 20 years.

5. Karnofsky Performance Status = 60.

6. Life expectancy of = 4 months.

7. Women of childbearing potential and male participants must practice adequate
contraception.

8. Patients must be able to comply with the study protocol and follow-up schedules and
provide study-specific informed consent.

Exclusion criteria Patients fulfill any of the following criteria will be excluded from
this trial

1. Serum creatinine > 2.0 mg/dL within 30 days prior registration

2. Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or
foreign bodies, severe claustrophobia

3. Patients with evidence of bleeding diathesis or coagulopathy, international normalized
ratio (INR) >1.5

4. Patients who require the use of warfarin sodium > 1 mg

5. Patients with active GI ulcers, GI bleeding, or active inflammatory bowel disease

6. Patients with clinically significant cardiac disease (e.g., uncontrolled hypertension
[blood pressure of >160/90 mmHg on medication], history of myocardial infarction or
unstable angina within 12 months of registration), New York Heart Association (NYHA)
Class II or greater congestive heart failure, unstable symptomatic arrhythmia
requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial
fibrillation or paroxysmal supraventricular tachycardia) are not eligible

7. Patients with a history of aneurysms, cerebrovascular accident (CVA) and arteriovenous
malformations

8. Patients with arterial thromboembolic events, including transient ischemic attack
(TIA), or clinically significant peripheral artery disease within 6 months of
registration

9. Patients with serious, non-healing wound, ulcer, or current healing fracture

10. Patients with a history of any type of fistula (vesicovaginal, gastrointestinal, etc)
or gastrointestinal perforation

11. Severe, active comorbidities which, in the judgment of the investigator, would make
the patient inappropriate for entry into this study or interfere significantly with
the proper assessment of safety and adverse events of the protocol, or limit
compliance with study requirements, defined as follows:

1. Uncontrolled active infection requiring intravenous antibiotics at the time of
registration

2. Transmural myocardial infarction = 6 months prior to registration

3. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

5. Uncontrolled psychiatric disorder

12. Will receive any other investigational agent or chemotherapy and/or target therapies
during SRS

13. Women of childbearing potential and male participants who are sexually active and not
willing/able to use medically acceptable forms of contraception; this exclusion is
necessary because the radiation treatment involved in this study may be significantly
teratogenic
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02672995      |      Link to official Clinicaltrials.gov listing
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