A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 91
- Locations
- 5
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Radiation Therapy Treatment
Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
Intervention: Whole Brain XRT 30Gy/10 fractions with (Radiation)
Outcomes
Primary Outcomes
Overall survival
Time Frame: At approximately end of year 4 (study completion)
Local disease control rate at 6 months
Time Frame: At approximately 2.5 years
CNS disease control rate at 6 months
Time Frame: At approximately 2.5 years
Secondary Outcomes
- Acute toxicity(At approximately end of year 4 (study completion))
- 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))
- Late toxicity(At approximately end of year 4 (study completion))
- Changes in MRI endpoints(Measured at baseline, and 3 months and 6 months post-treatment)
Investigators
George Rodrigues
Principal Investigator
Lawson Health Research Institute