NCT01507506: SPECTRO GLIO

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

Terminated Phase 3 Last updated 14 April 2026

What this trial tests

Phase 3 trial testing Radiotherapy in Glioblastoma in 180 participants. Terminated before completion.

Timeline

15 March 2011

Primary endpoint
2 January 2020

2 January 2020

Quick facts

Lead sponsor	Institut Claudius Regaud
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	15 March 2011
Primary completion	2 January 2020
Estimated completion	2 January 2020
Sites	12 locations across France

Drugs / interventions tested

• Radiotherapy — full drug profile →
• Experimental arm

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Institut Claudius Regaud — full company profile →

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiotherapy of high-grade gliomas: current standards and new concepts, innovations in imaging and radiotherapy, and new therapeutic approaches.
   Dhermain F. · · 2014 · cited 55× · PMID 24384237 · DOI 10.5732/cjc.013.10217
2. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.
   Cihoric N, Tsikkinis A, Minniti G, Lagerwaard FJ, et al · · 2017 · cited 54× · PMID 28049492 · DOI 10.1186/s13014-016-0740-5
3. Glioblastoma multiforme: emerging treatments and stratification markers beyond new drugs.
   von Neubeck C, Seidlitz A, Kitzler HH, Beuthien-Baumann B, et al · · 2015 · cited 47× · PMID 26159214 · DOI 10.1259/bjr.20150354
4. The Use of Quantitative Imaging in Radiation Oncology: A Quantitative Imaging Network (QIN) Perspective.
   Press RH, Shu HG, Shim H, Mountz JM, et al · · 2018 · cited 38× · PMID 29966725 · DOI 10.1016/j.ijrobp.2018.06.023
5. Advanced Imaging Techniques for Radiotherapy Planning of Gliomas.
   Castellano A, Bailo M, Cicone F, Carideo L, et al · · 2021 · cited 36× · PMID 33802292 · DOI 10.3390/cancers13051063
6. 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.
   Laprie A, Ken S, Filleron T, Lubrano V, et al · · 2019 · cited 30× · PMID 30791889 · DOI 10.1186/s12885-019-5317-x
7. Randomized phase III trial of metabolic imaging-guided dose escalation of radio-chemotherapy in patients with newly diagnosed glioblastoma (SPECTRO GLIO trial).
   Laprie A, Noel G, Chaltiel L, Truc G, et al · · 2024 · cited 21× · PMID 37417948 · DOI 10.1093/neuonc/noad119
8. Do perfusion and diffusion MRI predict glioblastoma relapse sites following chemoradiation?
   Khalifa J, Tensaouti F, Lotterie JA, Catalaa I, et al · · 2016 · cited 18× · PMID 27502603 · DOI 10.1007/s11060-016-2232-8