Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Objective response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
experimental arm
Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases.
Intervention：tomotherapy
Intervention: tomotherapy (Radiation)
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 2-3 months after radiation
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
Secondary Outcomes
- Overall survival rate(up to 3 years)
- progress free survival rate(up to 1 year)
- local control rate(up to 1 year)
- intracranial progress free survival rate(up to 1 year)
- adverse event(from the day of radiation, up to 6 months)
- cause of death(from the day of radiation to death date, up to 5 years)
Investigators
Jianping Xiao
Dr
Chinese Academy of Medical Sciences