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

Lawson Health Research Institute

Status and phase

Completed

Phase 2

Conditions

Metastasis to Brain of Primary Cancer

Treatments

Radiation: Whole Brain XRT 30Gy/10 fractions with

Study type

Interventional

Funder types

Other

Identifiers

NCT01543542

16776 (Other Identifier)

R-10-204

Details and patient eligibility

About

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.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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