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

Institut Claudius Regaud

Status and phase

Terminated

Phase 3

Conditions

Glioblastoma

Treatments

Radiation: Radiotherapy

Radiation: Experimental arm

Study type

Interventional

Funder types

Other

Identifiers

NCT01507506

08 TETE 01

Details and patient eligibility

About

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).

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
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