Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma (SPECTRO GLIO)
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ClinicalTrials.gov Identifier: NCT01507506 |
Recruitment Status :
Terminated
First Posted : January 11, 2012
Last Update Posted : January 12, 2021
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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 :
- Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide
- Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring will be regular and standardized. The main objective of this study is to improve overall survival of patients treated in experimental group (with simultaneous integrated boost).
Condition or disease | Intervention/treatment | Phase |
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Glioblastoma | Radiation: Radiotherapy Radiation: Experimental arm | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Randomized Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma : Standard 3D Conformational Radiotherapy Versus Intensity-modulated Radiotherapy With Simultaneous-integrated Boost Guided by Magnetic Resonance Spectroscopic Imaging |
Actual Study Start Date : | March 15, 2011 |
Actual Primary Completion Date : | January 2, 2020 |
Actual Study Completion Date : | January 2, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Conventional arm
3-dimensional conformal radiotherapy + Temozolomide
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Radiation: Radiotherapy
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 :
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Experimental: Experimental arm
simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide
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Radiation: Experimental arm
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 :
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- Overall survival defined as the time from randomization to the date of death or date of last follow-up news (censured data) [ Time Frame: 8 years ]
- Progression-free survival, defined as the time from randomization to the date of progression or death [ Time Frame: 8 years ]
- Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events)V3.0 [ Time Frame: 8 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Patients must have unifocal glioblastoma (grade IV astrocytoma, WHO classification). The GBM can be:
- Or resectable and the patient has received curative surgery
- Or unresectable, and the largest tumor diameter (contrast enhancement) must be less than 5 cm on MRI
- 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
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Abnormal haematological results at inclusion with:
- Neutrophils < 1500/mm3
- Blood-platelets < 100000/mm3
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507506
France | |
Clinique Claude Bernard | |
Albi, France, 81000 | |
Centre Jean Perrin | |
Clermont-ferrand, France, 63011 | |
Centre Georges François Leclerc | |
Dijon, France, 21000 | |
Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer) | |
Lyon, France, 69002 | |
Centre Leon Berard | |
Lyon, France, 69373 | |
AP HM - Hôpital La Timone | |
Marseille, France, 13385 | |
Centre Val d'Aurelle | |
Montpellier, France, 34298 | |
Institut de Cancerologie Lucien Neuwirth | |
Saint-Priest-En-Jarez, France, 42271 | |
Centre Paul Strauss | |
Strasbourg, France, 67065 | |
CHU de Strasbourg | |
Strasbourg, France, 67065 | |
Institut Claudius REGAUD | |
Toulouse, France, 31052 | |
Centre Marie Curie | |
Valence, France, 26953 |
Responsible Party: | Institut Claudius Regaud |
ClinicalTrials.gov Identifier: | NCT01507506 |
Other Study ID Numbers: |
08 TETE 01 |
First Posted: | January 11, 2012 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
Glioblastoma Radiotherapy Intensity modulated radiation therapy (IMRT) Magnetic resonance spectroscopic imaging (MRSI) |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |