Recurrent Glioma (Glioblastoma Multiforme) Clinical Trial
— GLIAAOfficial title:
Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial
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.
| Status | Not yet recruiting |
| Enrollment | 200 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Radiotherapy, University Hospital Freiburg | Freiburg i. Br. | Baden-Wuerttemberg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Freiburg | AG-NUK-RT, Clinical Trials Center Freiburg, University of Freiburg |
Germany,
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. — View Citation
Grosu AL, Lachner R, Wiedenmann N, Stärk 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. — View Citation
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. Review. — View Citation
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. — View Citation
Grosu AL, Weber WA, Franz M, Stärk 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. — View Citation
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. — View Citation
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. Review. — View Citation
Weber WA, Wester HJ, Grosu AL, Herz M, Dzewas B, Feldmann HJ, Molls M, Stöcklin 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 6 months after randomization | No | |
| Secondary | Overall survival | Kaplan-Meier: Performed on the per protocol population - all patients who are eligible and have started their allocated treatment | 1 year after randomisation | No |
| Secondary | Volumetrical assessment of GTV and PTV | Volumetrical assessment of delineated gross tumor volume (GTV) and planning target volume (PTV) based on AA-PET vs. delineated GTV/PTV based on T1-Gd-MRI. | Interim analysis | No |
| Secondary | Topography of recurrence | local relationship between recurrence and AA-PEt and MRI-derived TV | Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months) | No |
| Secondary | Localisation of necrosis after re-irradiation | Follow up (end of radiotherapy, 6 and 12 weeks after radiotherapy, then every 3 months) | Yes | |
| Secondary | Rate of long-term survivors | Rate of long-term survivors = Survivors > 1 year after randomisation | Follow up | No |
| Secondary | Quality of Life (QoL) | QoL assessed by the EORTC QlQ-C 15 PAL questionnaire | During Radiotherapy and Follow Up | No |
| Secondary | Rate of side effects | Assessed according to CTCAE | During Radiotherapy and Follow Up | Yes |