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Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme

NCT01252459 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-12-16

No results posted yet for this study

Summary

This study is designed to evaluate the impact of radiotherapy target volume delineation based on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted MRI (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well as concerning therapeutic safety of the respective strategy.

Conditions

  • Recurrent Glioma (Glioblastoma Multiforme)

Interventions

RADIATION

Radiation Therapy

Experimental intervention (Arm A): High-precision re-irradiation (stereotactic fractionated radiation therapy (SFRT) and/or image guided radiation therapy, (IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on AA-PET: GTV = AA uptake on PET, clinical target volume (CTV) = GTV+3mm, PTV = CTV+2mm

RADIATION

Radiation Therapy

Control intervention (Arm B): High-precision re-irradiation (SFRT and/or IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on T1Gd-MRI: GTV = contrast enhancement on T1Gd-MRI, CTV = GTV+3mm, PTV = CTV+2mm

Sponsors & Collaborators

  • Clinical Trials Center Freiburg

    collaborator UNKNOWN

  • University of Freiburg

    collaborator OTHER

  • AG-NUK-RT

    collaborator UNKNOWN

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Anca-Ligia Grosu, Prof. Dr. med. · Department of Radiotherapy, University Hospital Freiburg

  • Wolfgang Weber, Prof. Dr. med. · Department of Nuclear Medicine, University Hospital Freiburg

  • Ursula Nestle, PD Dr. med. · Department of Radiotherapy, University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-07-31
Completion
2014-07-31

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01252459 on ClinicalTrials.gov