NCT00250211

Brief Summary

The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 24, 2016

Status Verified

October 1, 2011

Enrollment Period

6 years

First QC Date

November 4, 2005

Last Update Submit

February 23, 2016

Conditions

GlioblastomaGlioma

Keywords

magnetic resonance imaging, functionalradiation therapytemozolomidefunctional imagingconcurrent chemoradiation

Outcome Measures

Primary Outcomes (2)

  • determine tumor response and pattern of failure using functional MRI imaging

    Study completion

  • time to disease progression

    Study completion

Secondary Outcomes (3)

  • distinguish residual tumor from treatment-related necrosis

    study completion

  • survival

  • acute late toxicity of tomotherapy and hypofractionation

Interventions

Functional MRI imaging and tomotherapyPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed glioblastoma multiforme
  • Ages 18-65
  • Karnofsky Performance Scale (KPS) equal to or less than 70
  • Minimal neurological deficit
  • Eligible for concurrent temozolomide chemotherapy

You may not qualify if:

  • Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

GlioblastomaGlioma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Bassam Abdulkarim, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 8, 2005

Study Start

March 1, 2005

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

February 24, 2016

Record last verified: 2011-10

Locations

CA(1)