Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma

NCT01507506 | Terminated Phase 3

• 1 other identifier: 08 TETE 01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 12

Brief Summary

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).

Conditions

Glioblastoma

Keywords

Glioblastoma; Radiotherapy; Intensity modulated radiation therapy (IMRT); Magnetic resonance spectroscopic imaging (MRSI)

Outcome Measures

Primary Outcomes (1)

• Overall survival defined as the time from randomization to the date of death or date of last follow-up news (censured data)

  8 years

Secondary Outcomes (2)

• 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

Study Arms (2)

Conventional arm

ACTIVE COMPARATOR

3-dimensional conformal radiotherapy + Temozolomide

Radiation: Radiotherapy

Experimental arm

EXPERIMENTAL

simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide

Radiation: Experimental arm

Interventions

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 : * during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day, * post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32.

Conventional arm

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 : * during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day, * post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32.

Experimental arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Patient under legal guardianship

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (12)

Clinique Claude Bernard

Albi, 81000, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Georges François Leclerc

Dijon, 21000, France

Location

Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer)

Lyon, 69002, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

AP HM - Hôpital La Timone

Marseille, 13385, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Institut de Cancerologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

CHU de Strasbourg

Strasbourg, 67065, France

Location

Institut Claudius REGAUD

Toulouse, 31052, France

Location

Centre Marie Curie

Valence, 26953, France

Location

Related Publications (3)

• 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.

  PMID: 37417948 RESULT

• 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.

  PMID: 30791889 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.

  PMID: 26189058 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; 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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 11, 2012
• Study Start: March 15, 2011
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2020
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (12)