Brain Neoplasm Clinical Trial
Official title:
Fractionated Stereotactic Radiosurgery With Concurrent Bevacizumab for Brain Metastases: A Phase I Dose-escalation Trial
The investigators propose a new treatment strategy of fractionated stereotactic radiosurgery with concurrent bevacizumab for brain metastases. This phase I dose-escalation study is to establish the feasibility of this strategy and find the recommended doses.
For each group (two groups according to tumor size), the design proceeds with cohorts of
three patients, with the first cohort treated at a starting dose. If none of the three
patients in a cohort experiences a dose-limiting toxicity (DLT), the next cohort with three
patients will be treated at the next higher dose level. If one of the first three patients
experiences a dose-limiting toxicity, the next cohort will be treated at the same dose level.
The dose escalation continues until at least two patients among a cohort of three to six
patients experience DLTs and the maximum tolerated dose (MTD) will be the dose level just
below. If the highest planned dose was achieved without two patients experiencing DLTs, the
MTD will be that dose level.
The DLT is defined as grade 4 or above toxicities according to the Common Terminology
Criteria for Adverse Events (CTCAE) version 4.03 within 4 months after stereotactic
radiosurgery (SRS):
Grade 4 central nervous system necrosis (life-threatening consequences; urgent intervention
indicated) Grade 4 sensory or motor neuropathy (life-threatening consequences; urgent
intervention indicated) Grade 4 hemorrhage (life-threatening consequences; urgent
intervention indicated) or Grade 4 thromboembolic event (life-threatening consequences such
as pulmonary embolism, cerebrovascular event, arterial insufficiency; hemodynamic or
neurologic instability; urgent intervention indicated) Grade 4 hypertension (life-threatening
consequences such as malignant hypertension, transient or permanent neurologic deficit,
hypertensive crisis; urgent intervention indicated)
Study treatment:
Fractionated stereotactic radiosurgery:
Group 1: tumors 1.5~2.5 cm in diameter Dose level 1: 21 Gy in 3 fractions Dose level 2: 24 Gy
in 3 fractions Dose level 3: 27 Gy in 3 fractions Group 2: tumors 2.5~3.5 cm in diameter Dose
level 1: 18 Gy in 3 fractions Dose level 2: 21 Gy in 3 fractions Dose level 3: 24 Gy in 3
fractions Three fractions will be given in one week with at least 1 day break.
Concurrent bevacizumab:
Bevacizumab 7.5 mg/kg will be given one day before the first fraction of radiosurgery and 2
weeks after the first dose of bevacizumab.
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