A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases

Study Overview
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Brief Summary
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Helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy imaging of the body. This new machine can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with existing radiation machines. In this study, helical tomotherapy will be used to provide radiation treatments (whole brain radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to the brain. In addition, the individual spots of cancer (metastases) in the brain will be treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The purpose of this study is to determine the effectiveness of whole brain radiation with lesion boosting with the helical tomotherapy machine.

Official Title
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A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases

Conditions
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Metastasis to Brain of Primary Cancer

Intervention / Treatment
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* Radiation: Whole Brain XRT 30Gy/10 fractions with


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of primary cancer Contrast enhanced MRI demonstrating 1-3 metastases within 6 weeks of enrollment Age greater than or equal to 18 Karnofsky performance status greater than or equal to 70 Patient available for subsequent follow-up appointments and testing as well as health-related quality of life questionnaires Anticipated survival (independent of the brain metastases) greater than 3 months Patient informed consent obtained Metastatic suitable for synchronous boost Extracranial disease controlled or to be treated Exclusion Criteria: Underlying medical condition precluding adequate follow-up Prior cranial radiotherapy Concurrent cytotoxic chemotherapy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Other: Radiation Therapy Treatment<br>Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy | Radiation: Whole Brain XRT 30Gy/10 fractions with<br>* 30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | At approximately end of year 4 (study completion) | 
| Local disease control rate at 6 months |  | At approximately 2.5 years | 
| CNS disease control rate at 6 months |  | At approximately 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of RTOG versus RECIST versus Volumetric MRI criteria |  | At approximately end of year 4 (study completion) | 
| Health related quality of life |  | At approximately end of year 4 (study completion) | 
| Karnofsky performance status |  | AT approximately end of year 4 (study completion) | 
| Mini mental status exam cognition |  | At approximately end of year 4 (study completion) | 
| Acute toxicity |  | At approximately end of year 4 (study completion) | 
| Late toxicity |  | At approximately end of year 4 (study completion) | 
| Changes in MRI endpoints | Assessment in changes of diffusional weighted imaging and magnetic resonance spectroscopy. Changes at 3 months post-treatment and 6 months post-treatment will be compared to baseline (pre-treatment). | Measured at baseline, and 3 months and 6 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1-3 brain metastases from any primary cancer