Minimized Time to Beam in Patients With High Grade Gliomas

NCT00469534 | Withdrawn DMC

• 1 other identifier: CNS-9-0039
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

High Grade Glioma

Keywords

minimized time to beam; hypofractionated 3D CRT plus IMRT; PET-scan

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

IMRT PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histopathologically-confirmed high grade glioma
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alberta Health services: lead

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Albert Murtha, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Last Updated: September 22, 2011

Record last verified: 2011-09