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TERMINATED
NCT01507506
PHASE3

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

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2011-03-15

Completion Date

2020-01-02

Last Updated

2026-04-14

Healthy Volunteers

No

Conditions

Interventions

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 : * 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.

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 : * 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.

Locations (12)

Clinique Claude Bernard

Albi, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

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

Lyon, France

Centre Leon Berard

Lyon, France

AP HM - Hôpital La Timone

Marseille, France

Centre Val d'Aurelle

Montpellier, France

Institut de Cancerologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

Centre Paul Strauss

Strasbourg, France

CHU de Strasbourg

Strasbourg, France

Institut Claudius REGAUD

Toulouse, France

Centre Marie Curie

Valence, France