Status:

TERMINATED

Positron Emission Tomography-Computed Tomography (PET-CT) High-grade Glioma

Lead Sponsor:

Maastricht Radiation Oncology

Collaborating Sponsors:

Maastricht University Medical Center

Conditions:

Cerebral Astrocytoma, High Grade

Eligibility:

All Genders

19+ years

Brief Summary

The objectives of the trial are: * To determine the localisation within the primary tumor of the therapy resistant cells, before and during radiotherapy to determine a possible accurate boost volume....

Detailed Description

Patients harboring a primary intracerebral high grade tumor (WHO III- IV) have a median survival of six to 12 months. Combined chemoradiotherapy with temozolomide is now the standard of care since res...

Eligibility Criteria

Inclusion

  • Histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
  • WhO PFS \<= 2
  • Tumours which do enhance on pre-operative imaging.
  • Post-operative enough visible residual tumour on PET or status after biopsy only
  • Age \>18 years
  • Availability of deep fresh frozen tissue for molecular biologic evaluation - if possible
  • Patient able to tolerate full course of conventional RT and follow serial scanning
  • No previous radiotherapy to the head and neck and brain area.
  • Prior neurosurgery within 6 weeks of treatment
  • No previous chemotherapy before treatment of the glioma. Standard radiochemotherapy with temozolomide is not excluded
  • No prior or concurrent medical condition which would make treatment difficult to complete. Medication with steroids is allowed.
  • No incapacitated patients.

Exclusion

  • Not histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
  • WhO PFS \> 2
  • No tumours which do enhance on pre-operative imaging.
  • Post-operative not enough visible residual tumor on PET or status after biopsy only
  • Age \<18 years
  • No availability of deep fresh frozen tissue for molecular biologic evaluation
  • Patient not able to tolerate full course of conventional RT and follow serial scanning
  • Previous radiotherapy to the head and neck and brain area.
  • Prior neurosurgery not within 6 weeks of treatment
  • Previous chemotherapy before treatment of the glioma.
  • Prior or concurrent medical condition which would make treatment difficult to complete.
  • Incapacitated patients.

Key Trial Info

Start Date :

June 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00643591

Start Date

June 1 2008

End Date

June 1 2010

Last Update

April 10 2015

Active Locations (1)

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Maastricht Radiation Oncology

Maastricht, Netherlands, 6202 AZ