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

NCT ID: NCT01543542

Last Updated: 2016-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastasis to Brain of Primary Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiation Therapy Treatment

Whole Brain XRT 30Gy/10 fractions with Simultaneous Infield Boost of Brain Lesions to 60Gy

Group Type OTHER

Whole Brain XRT 30Gy/10 fractions with

Intervention Type RADIATION

30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole Brain XRT 30Gy/10 fractions with

30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ontario Institute for Cancer Research

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

George Rodrigues

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

George Rodrigues, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Program of the Lawson Health Research Institute

Glenn Bauman, MD

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Program of the Lawson Health Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alberta Health Services, Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, Canada

Site Status

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Site Status

Centre Hospitalier De L'Universite de Montreal

Montreal, Quebec, Canada

Site Status

McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Rodrigues 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.

Reference Type DERIVED
PMID: 22436144 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16776

Identifier Type: OTHER

Identifier Source: secondary_id

R-10-204

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Perfexion Brain Metastasis
NCT00805103 TERMINATED PHASE1