Clinical trial · Interventional
A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases
A Phase II Multi-institutional Study Assessing Simultaneous In-Field Boost Helical Tomotherapy for 1-3 Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis to Brain of Primary Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole Brain XRT 30Gy/10 fractions with | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Radiation Therapy Treatment
- description
- Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy
- interventionNames
- Radiation: Whole Brain XRT 30Gy/10 fractions with
Primary outcomes (3)
- measure
- Overall survival
- timeFrame
- At approximately end of year 4 (study completion)
- measure
- Local disease control rate at 6 months
- timeFrame
- At approximately 2.5 years
- measure
- CNS disease control rate at 6 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRodrigues G, Yartsev S, Tay KY, Pond GR, Lagerwaard F, Bauman G. A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases. Radiat Oncol. 2012 Mar 21;7:42. doi: 10.1186/1748-717X-7-42. PMID 22436144