Clinical trial NCT03027544: Tomotherapy for Refractory Brain Metastases
Official title: Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Metastases
Keywords: multiple brain metastases
large brain metastases
meningeal metastases
tomotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2017-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.

Detailed description: This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc; KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old;

Adequate end-organ function:

WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range.

Exclusion Criteria:

* • Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).

  * Unable or unwilling to comply with the study protocol.
  * The expected survival time is less than 3 months.
  * Patients who are anticipated in other clinical trials of brain metastases.
  * Patients who has been treated with SRT in other hospitals
  * Pregnant patients or female patients whose HCG is positive
  * Unsuitable to participate in study, that in the opinion of the treating physician.

Primary outcomes:
measure: Objective response rate
timeFrame: 2-3 months after radiation
Secondary outcomes:
measure: Overall survival rate
timeFrame: up to 3 years
measure: progress free survival rate
timeFrame: up to 1 year
measure: local control rate
timeFrame: up to 1 year
measure: intracranial progress free survival rate
timeFrame: up to 1 year
measure: adverse event
timeFrame: from the day of radiation, up to 6 months
measure: cause of death
timeFrame: from the day of radiation to death date, up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Jianping Xiao
role: PRINCIPAL_INVESTIGATOR
References: