Clinical trial NCT02654106: Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases
Official title: Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Metastases
Keywords: multiple brain metastases
large brain metastases
meningeal metastases
fractionated stereotactic radiotherapy
temozolomide
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Cancer Foundation, China
First posted: 2016-01-13
Enrollment: 65
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 fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

Detailed description: This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ 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: intracranial progress free survival rate
timeFrame: up to 2 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: up to 3 year
measure: progress free survival rate
timeFrame: up to 1 year
measure: local control rate
timeFrame: up to 1 year
measure: disease control rate (DCR)
timeFrame: 2-3 months after radiation
measure: adverse event
timeFrame: from the day of radiation to the end of adjuvant TMZ，up to 6 months
measure: causes 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:
citation: Bi N, Ma Y, Xiao J, Zhang H, Xu Y, Tian Y, Li J, Zhang Y, Liu Q, Wang K, Deng L, Wang W, Chen X, Liu F, Zhao R, Yang S, Huang X, Yi J, Hu C, Li Y. A Phase II Trial of Concurrent Temozolomide and Hypofractionated Stereotactic Radiotherapy for Complex Brain Metastases. Oncologist. 2019 Sep;24(9):e914-e920. doi: 10.1634/theoncologist.2018-0702. Epub 2019 Apr 17.