Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

Study Overview
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Brief Summary
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This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.

Detailed Description
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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).

Official Title
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Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial

Conditions
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Brain Metastases

Intervention / Treatment
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* Radiation: tomotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT). | Radiation: tomotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate(DCR) | Using RTOG9508 criteria, tumor control is defined as CR+PR+SD | 2-3 month after radiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the time from radiation to death | up to 3 years | 
| progress free survival | the time from radiation to any progression | up to 1 year | 
| local control rate | the time from radiation to the treated brain metastases recurrence | up to 1 year | 
| intracranial progress free survival rate | the time from radiation to local recurrence and/or new brain metastases | up to 1 year | 
| adverse event | acute and late toxicities | from the day of radiation, up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple brain metastases, Tomotherapy, fractionated stereotactic radiotheray