Minimized Time to Beam in Patients With High Grade Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469534
Recruitment Status : Withdrawn
First Posted : May 4, 2007
Last Update Posted : September 22, 2011
Information provided by:
AHS Cancer Control Alberta

Brief Summary:

A Pilot Study Evaluating Minimized Time to Beam Hypofractionated IMRT with PET Assisted Target Definition in Patients with High Grade Gliomas

The aim of this pilot project is to explore the feasibility of combining a simple conformal plan (Phase I) with an IMRT treatment approach (Phase II) for high grade glioma patients with the aim of starting the RT as soon as possible following the patient's first outpatient visit (thus, minimized 'time to beam'). It is hoped that the rapid treatment start with the initial 3D CRT plan will lessen clinical deterioration due to the growth of these aggressive tumours. The use of Linac-based IMRT in Phase II of the patient's treatment plan will maintain the benefit of the sophistication of IMRT.

Using novel PET imaging we also hope to better characterize regions of glioma cells thus producing more optimized planning target volumes (PTVs) for each patient and decreasing the volume of normal brain irradiated with the aim of minimizing radiation toxicities. Hopefully this planning and treatment approach will provide an improvement in the quality of life and outcome for high grade glioma patients.

Condition or disease Intervention/treatment Phase
High Grade Glioma Procedure: IMRT Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Minimized Time to Beam Hypofractionated IMRT With PET-Assisted Target Definition in Patients With High Grade Gliomas

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Time from initial OPD visit to start of RT compared with historical controls receiving helical tomotherapy base IMRT (Time to Beam).

Secondary Outcome Measures :
  1. Overall survival, disease-free survival, patterns of recurrence, toxicity, quality of life, number of patients who complete treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histopathologically-confirmed high grade glioma
  • 18+ years of age
  • no prior radiation therapy to the brain
  • no active prior malignancy
  • KPS greater or equal to 70
  • singed study-specific consent form

Exclusion Criteria:

  • no histopathologically confirmation of high grade glioma
  • less than 18 years of age
  • prior radiation therapy to the brain
  • active prior malignancy
  • KPS less than 70

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469534

Sponsors and Collaborators
Alberta Health Services
Principal Investigator: Albert Murtha, MD AHS Cancer Control Alberta Identifier: NCT00469534     History of Changes
Other Study ID Numbers: CNS-9-0039
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011

Keywords provided by AHS Cancer Control Alberta:
minimized time to beam
hypofractionated 3D CRT plus IMRT

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue