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Minimized Time to Beam in Patients With High Grade Gliomas

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00469534
First received: May 2, 2007
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
High Grade Glioma
 Procedure: IMRT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Alberta Health Services:

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

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

Enrollment: 0
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469534

Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Albert Murtha, MD Alberta Health Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00469534     History of Changes
Other Study ID Numbers: CNS-9-0039
Study First Received: May 2, 2007
Last Updated: September 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
minimized time to beam
hypofractionated 3D CRT plus IMRT
PET-scan

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

ClinicalTrials.gov processed this record on May 16, 2013