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GlioblastomaPhase 3SPECTRO GLIONCT01507506

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

A Phase 3 study testing Radiotherapy and Experimental arm in people with Glioblastoma, run by Institut Claudius Regaud at 12 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Radiotherapy and Experimental arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
12 sitesFrance
Study dates
15 Mar 2011to 2 Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Clinique Claude Bernard

    Albi, 81000

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc

    Dijon, 21000

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

    Lyon, 69002

  • Centre Leon Berard

    Lyon, 69373

  • AP HM - Hôpital La Timone

    Marseille, 13385

  • Centre Val d'Aurelle

    Montpellier, 34298

  • Institut de Cancerologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Centre Paul Strauss

    Strasbourg, 67065

  • CHU de Strasbourg

    Strasbourg, 67065

  • Institut Claudius REGAUD

    Toulouse, 31052

  • Centre Marie Curie

    Valence, 26953

Other trials in France

About this study

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

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
Being tested
Radiotherapy, Experimental arm
Keywords
Glioblastoma, Radiotherapy, Intensity modulated radiation therapy (IMRT), Magnetic resonance spectroscopic imaging (MRSI)
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    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.

  • Experimental armRadiation

    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.
Study groups in NCT01507506
Study groupRoleWhat they receive
Conventional armActive comparator3-dimensional conformal radiotherapy + Temozolomide
Receives: Radiation: Radiotherapy
Experimental armExperimentalsimultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide
Receives: Radiation: Experimental arm

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 years

Secondary outcomes (2)

  1. Progression-free survival, defined as the time from randomization to the date of progression or death

    Measured: 8 years

  2. Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events)V3.0

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2012 (estimated)
  2. Study start15 Mar 2011
  3. Primary completion2 Jan 2020
  4. Study completion2 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01507506
Sponsor's protocol ID
08 TETE 01
Acronym
SPECTRO GLIO
Status last verified
Apr 2026
First submitted
20 Dec 2011
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37417948

  • 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.

    PubMed 30791889

  • 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.

    PubMed 26189058

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiotherapy and Experimental arm in people with Glioblastoma, run by Institut Claudius Regaud at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01507506, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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SPECTRO GLIO Clinical Trial NCT01507506 | AzTrials