Brain Metastases
Conditions
Keywords
multiple brain metastases, Tomotherapy, fractionated stereotactic radiotheray
Brief summary
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.
Detailed description
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).
Interventions
RADIATIONtomotherapy
Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2\*5d, q28d, up to 6cycles.
Sponsors
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;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 organ function:WBC≥4.0x109/L, Neu ≥ 1.5x109/L, Hemoglobin ≥ 110 g/L, Platelets ≥100 x109/L, Totalbilirubin ≤ 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 WBRT. 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 |
|---|---|---|
| Disease control rate(DCR) | 2-3 month after radiation | Using RTOG9508 criteria, tumor control is defined as CR+PR+SD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 3 years | the time from radiation to death |
| progress free survival | up to 1 year | the time from radiation to any progression |
| local control rate | up to 1 year | the time from radiation to the treated brain metastases recurrence |
| intracranial progress free survival rate | up to 1 year | the time from radiation to local recurrence and/or new brain metastases |
| adverse event | from the day of radiation, up to 3 years | acute and late toxicities |
Countries
China
Outcome results
None listed