Brain Metastases
Conditions
Keywords
multiple brain metastases, large brain metastases, meningeal metastases, fractionated stereotactic radiotherapy, temozolomide
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.
Interventions
The regular fraction modes were as follows: a. lesions≥3 cm：52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm：36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm：40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem：50-60Gy/2.5-3Gy/20f.
DRUGTemozolomide
concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2\*5d, q28d, 6cycles
Sponsors
Cancer Foundation, China
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intracranial progress free survival rate | up to 2 years | defined as no progress of the treated lesions and no distant progress in the brain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progress free survival rate | up to 1 year | — |
| local control rate | up to 1 year | — |
| Overall survival rate | up to 3 year | — |
| adverse event | from the day of radiation to the end of adjuvant TMZ，up to 6 months | assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system |
| causes of death | from the day of radiation to death date, up to 5 years | collect the data of causes of death and analyze |
| disease control rate (DCR) | 2-3 months after radiation | Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD |
Countries
China
Outcome results
None listed