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

NCT01252459 | Unknown Phase 2 DMC

• 1 other identifier: AG NUK/RT 2010-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

AA-PET; T1-Gd-MRI; re-irradiation; recurrent glioma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  6 months after randomization

Secondary Outcomes (7)

• Overall survival

  1 year after randomisation

• Volumetrical assessment of GTV and PTV

  Interim analysis

• Topography of recurrence

  Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months)

• Localisation of necrosis after re-irradiation

  Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months)

• Rate of long-term survivors

  Follow up

Study Arms (2)

Arm A: AA-PET based target volume delineation

EXPERIMENTAL

Experimental intervention (Arm A): High-precision re-irradiation. Target volume delineation based on AA-PET.

Radiation: Radiation Therapy

Arm B: T1Gd-MRI based target volume delineation

ACTIVE COMPARATOR

Control intervention (Arm B): High-precision re-irradiation. Target volume delineation based on T1Gd-MRI.

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

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

Arm A: AA-PET based target volume delineation

Eligibility Criteria

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

You may qualify if:

• Local recurrence of GBM (WHO grade IV) and either not eligible for tumor resection or with macroscopic residual tumor after resection of recurrent GBM
• Recurrent tumor visible on AA-PET and MRI-T1-Gd with the diameter measuring 1 cm to 6 cm by either technique
• Target volume definition possible according to both study arms
• Previous radiation therapy of the primary with a maximal total dose 60 Gy
• At least 9 months since the end of pre-irradiation and randomisation
• At most 2 prior chemotherapy regimes
• Start of radiation therapy possible within 2 weeks from AA-PET
• Karnofsky Performance Score (KPS) ≥ 70%
• Age ≥ 18 years
• Written informed consent (IC) obtained

You may not qualify if:

• \- No histological confirmation of Glioma at initial diagnosis)
• Recent (≤ 4 weeks before IC) histological result showing no tumor recurrence
• No recurrent tumor detectable on last AA-PET or MRI-T1-Gd
• Technical impossibility to use existing AA-PET for RT-planning
• No prior radiation treatment to the primary tumor
• less than 9 months between the end of first radiation treatment and randomisation
• more than 2 previous chemotherapy regimes or previous treatment with Avastin or other molecular targeted therapies
• less than 2 weeks between application of chemotherapy and randomisation
• additional chemotherapy or molecular targeted therapy or further surgery planned before diagnosis of further tumor progression after study intervention
• pregnancy, nursing or patient not willing to prevent pregnancy during treatment

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Clinical Trials Center Freiburg: collaborator
• University of Freiburg: collaborator
• AG-NUK-RT: collaborator

Study Sites (1)

Department of Radiotherapy, University Hospital Freiburg

Freiburg I. Br., Baden-Wurttemberg, 79106, Germany

Location

Related Publications (10)

• Grosu AL, Weber WA. PET for radiation treatment planning of brain tumours. Radiother Oncol. 2010 Sep;96(3):325-7. doi: 10.1016/j.radonc.2010.08.001. Epub 2010 Aug 20.

  PMID: 20728952 BACKGROUND

• Grosu AL, Weber WA, Franz M, Stark S, Piert M, Thamm R, Gumprecht H, Schwaiger M, Molls M, Nieder C. Reirradiation of recurrent high-grade gliomas using amino acid PET (SPECT)/CT/MRI image fusion to determine gross tumor volume for stereotactic fractionated radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):511-9. doi: 10.1016/j.ijrobp.2005.01.056.

  PMID: 16168843 BACKGROUND

• Grosu AL, Weber WA, Riedel E, Jeremic B, Nieder C, Franz M, Gumprecht H, Jaeger R, Schwaiger M, Molls M. L-(methyl-11C) methionine positron emission tomography for target delineation in resected high-grade gliomas before radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):64-74. doi: 10.1016/j.ijrobp.2005.01.045.

  PMID: 16111573 BACKGROUND

• Grosu AL, Piert M, Weber WA, Jeremic B, Picchio M, Schratzenstaller U, Zimmermann FB, Schwaiger M, Molls M. Positron emission tomography for radiation treatment planning. Strahlenther Onkol. 2005 Aug;181(8):483-99. doi: 10.1007/s00066-005-1422-7.

  PMID: 16044216 BACKGROUND

• Grosu AL, Lachner R, Wiedenmann N, Stark S, Thamm R, Kneschaurek P, Schwaiger M, Molls M, Weber WA. Validation of a method for automatic image fusion (BrainLAB System) of CT data and 11C-methionine-PET data for stereotactic radiotherapy using a LINAC: first clinical experience. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1450-63. doi: 10.1016/s0360-3016(03)00279-7.

  PMID: 12873691 BACKGROUND

• Grosu AL, Feldmann H, Dick S, Dzewas B, Nieder C, Gumprecht H, Frank A, Schwaiger M, Molls M, Weber WA. Implications of IMT-SPECT for postoperative radiotherapy planning in patients with gliomas. Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):842-54. doi: 10.1016/s0360-3016(02)02984-x.

  PMID: 12377338 BACKGROUND

• Weber WA, Wester HJ, Grosu AL, Herz M, Dzewas B, Feldmann HJ, Molls M, Stocklin G, Schwaiger M. O-(2-[18F]fluoroethyl)-L-tyrosine and L-[methyl-11C]methionine uptake in brain tumours: initial results of a comparative study. Eur J Nucl Med. 2000 May;27(5):542-9. doi: 10.1007/s002590050541.

  PMID: 10853810 BACKGROUND

• Grosu AL, Weber W, Feldmann HJ, Wuttke B, Bartenstein P, Gross MW, Lumenta C, Schwaiger M, Molls M. First experience with I-123-alpha-methyl-tyrosine spect in the 3-D radiation treatment planning of brain gliomas. Int J Radiat Oncol Biol Phys. 2000 May 1;47(2):517-26. doi: 10.1016/s0360-3016(00)00423-5.

  PMID: 10802381 BACKGROUND

• Grosu AL, Weber WA, Graf E, Mix M, Nestle U, Schimek-Jasch T, Wiehle R, Mader I, Wurtemberger U, Langen KJ, Niyazi M, Paulsen F, Konig L, Giordano FA, Spehl I, Bernhardt D, Schymalla MM, Pottgen C, Semrau S, Brunner T, Hultenschmidt B, Krause BJ, Ciernik IF, Beck J, Baumert BG, Meyer PT, Urbach H, Popp I; GLIAA Study Group. O-(2-[18F]fluoroethyl)-L-tyrosine-PET-guided versus contrast-enhanced T1-weighted MRI-guided re-irradiation in patients with recurrent glioblastoma (GLIAA/NOA-10 ARO2013-01): a multicentre, open-label, randomised trial. Lancet Oncol. 2025 Dec 19:S1470-2045(25)00642-4. doi: 10.1016/S1470-2045(25)00642-4. Online ahead of print.

  PMID: 41429128 DERIVED

• Oehlke O, Mix M, Graf E, Schimek-Jasch T, Nestle U, Gotz I, Schneider-Fuchs S, Weyerbrock A, Mader I, Baumert BG, Short SC, Meyer PT, Weber WA, Grosu AL. Amino-acid PET versus MRI guided re-irradiation in patients with recurrent glioblastoma multiforme (GLIAA) - protocol of a randomized phase II trial (NOA 10/ARO 2013-1). BMC Cancer. 2016 Oct 5;16(1):769. doi: 10.1186/s12885-016-2806-z.

  PMID: 27716184 DERIVED

MeSH Terms

Conditions

Glioblastoma; Glioma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Anca-Ligia Grosu, Prof. Dr. med.

  Department of Radiotherapy, University Hospital Freiburg

  STUDY CHAIR

• Wolfgang Weber, Prof. Dr. med.

  Department of Nuclear Medicine, University Hospital Freiburg

  STUDY CHAIR

• Ursula Nestle, PD Dr. med.

  Department of Radiotherapy, University Hospital Freiburg

  STUDY CHAIR

Central Study Contacts

Anca-Ligia Grosu, Prof. Dr. med.

CONTACT

0049-761-270; gliaa@uniklinik-freiburg.de

Ursula Nestle, PD Dr. med.

CONTACT

0049-761-270; gliaa@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: December 16, 2010

Record last verified: 2010-12

Locations

DE (1)