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This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up.
Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or surgical specimen) and who meet all eligibility criteria will be randomized in one chemoradiotherapy arm :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional arm | Active Comparator | 3-dimensional conformal radiotherapy + Temozolomide |
|
| Experimental arm | Experimental | simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Conventional arm: 3D conformational radiotherapy (arm A): 60 Gy per fractions of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with a linear accelerator equipped with a portal imaging. + Chemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie :
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival defined as the time from randomization to the date of death or date of last follow-up news (censured data) | 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, defined as the time from randomization to the date of progression or death | 8 years | |
| Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events)V3.0 | 8 years |
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Inclusion Criteria:
Patients must have unifocal glioblastoma (grade IV astrocytoma, WHO classification). The GBM can be:
In all cases, the diagnosis must be confirmed by a pathologist. In patients for whom surgery is not possible, the diagnosis is confirmed by a biopsy of tumor tissue.
Methylation status of MGMT gene promoter is known
Patients who have undergone resection should have received an MRI or a scan after surgery in order to visualize residual tumor. If not, the operative report must be available.
Surgery or biopsy must have occurred 45 days before the start of radiotherapy.
WHO ≤ 2
Age ≥ 18 years
Signed Consent collected before any specific procedure in the study
Patient member in a national insurance scheme
Exclusion Criteria:
Signs of hemorrhage on pre-radiotherapy MRI preventing a good spectrometric analysis
Patient with multifocal glioblastoma
Tumor located within 2 cm of the optic chiasm
Patient with leptomeningeal metastases,
patients prone to epileptic seizures despite treatment with anticonvulsant
Patients who received other previous treatment for glioblastoma multiforme
Abnormal haematological results at inclusion with:
Severe or chronic renal insufficiency (creatinin clearance ≤ 30 ml/min calculated using Cockroft-Gault's formula
Patient unable to follow procedures, visits, examinations described in the study
Any usual formal indication against imaging examinations (important claustrophobia, pace maker ...)
Pregnant women or nursing mothers can not participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry
Men and women of childbearing age must use effective contraception at study entry and throughout the study
Any concomitant or previous malignant disease within 5 years prior to study entry
Any prior systemic chemotherapy within 5 years prior to inclusion (for malignant disease in medical history)
Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
Patient under legal guardianship
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Claude Bernard | Albi | 81000 | France | |||
| Centre Jean Perrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37417948 | Result | Laprie A, Noel G, Chaltiel L, Truc G, Sunyach MP, Charissoux M, Magne N, Auberdiac P, Biau J, Ken S, Tensaouti F, Khalifa J, Sidibe I, Roux FE, Vieillevigne L, Catalaa I, Boetto S, Uro-Coste E, Supiot S, Bernier V, Filleron T, Mounier M, Poublanc M, Olivier P, Delord JP, Cohen-Jonathan-Moyal E. Randomized phase III trial of metabolic imaging-guided dose escalation of radio-chemotherapy in patients with newly diagnosed glioblastoma (SPECTRO GLIO trial). Neuro Oncol. 2024 Jan 5;26(1):153-163. doi: 10.1093/neuonc/noad119. | |
| 30791889 |
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|
| Experimental arm | Radiation | Conformational radiotherapy with simultaneous integrated boost by intensity modulation (Arm B): 60 Gy per fraction of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with concomitant daily superimposed boost on spectroscopic active region (PTV2) corresponding to the ratio Cho / NAA> 2 + 0.7 mm + contrast enhancement + 3mm. The PTV2 will receive a daily dose of 2.4 Gy for a cumulative dose of 72 Gy Only irradiation with simultaneous integrated boost are allowed + Chemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie :
|
|
| Clermont-Ferrand |
| 63011 |
| France |
| Centre Georges François Leclerc | Dijon | 21000 | France |
| Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer) | Lyon | 69002 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| AP HM - Hôpital La Timone | Marseille | 13385 | France |
| Centre Val d'Aurelle | Montpellier | 34298 | France |
| Institut de Cancerologie Lucien Neuwirth | Saint-Priest-en-Jarez | 42271 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| CHU de Strasbourg | Strasbourg | 67065 | France |
| Institut Claudius REGAUD | Toulouse | 31052 | France |
| Centre Marie Curie | Valence | 26953 | France |
| Derived |
| Laprie A, Ken S, Filleron T, Lubrano V, Vieillevigne L, Tensaouti F, Catalaa I, Boetto S, Khalifa J, Attal J, Peyraga G, Gomez-Roca C, Uro-Coste E, Noel G, Truc G, Sunyach MP, Magne N, Charissoux M, Supiot S, Bernier V, Mounier M, Poublanc M, Fabre A, Delord JP, Cohen-Jonathan Moyal E. Dose-painting multicenter phase III trial in newly diagnosed glioblastoma: the SPECTRO-GLIO trial comparing arm A standard radiochemotherapy to arm B radiochemotherapy with simultaneous integrated boost guided by MR spectroscopic imaging. BMC Cancer. 2019 Feb 21;19(1):167. doi: 10.1186/s12885-019-5317-x. |
| 26189058 | Derived | Ken S, Deviers A, Filleron T, Catalaa I, Lotterie JA, Khalifa J, Lubrano V, Berry I, Peran P, Celsis P, Moyal EC, Laprie A. Voxel-based evidence of perfusion normalization in glioblastoma patients included in a phase I-II trial of radiotherapy/tipifarnib combination. J Neurooncol. 2015 Sep;124(3):465-73. doi: 10.1007/s11060-015-1860-8. Epub 2015 Jul 19. |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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