Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults

Phase 1

Completed

• Conditions: Glioblastoma
• Interventions: Radiation: radiotherapy; Drug: temozolomide

• Registration Number: NCT01043536
• Lead Sponsor: Centre Georges Francois Leclerc

Brief Summary

The main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2012-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)
• Diagnosis must be obtained by a stereotactic or surgical biopsy
• Age between 18 and 70
• Total or partial surgical resection deemed as not possible by a neurosurgeon
• OMS performance status 0 or 1
• Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count > 100 x 109/L platelets;
• Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST < 3 ULN,
• Adequate renal function: creatinine < 1.5 ULN
• Patient must have been informed and must have signed the specific informed consent form.

Exclusion Criteria

• other malignancy histology
• resection of the brain tumor complete on MRI exploration
• patient unable to give informed consent
• patient presenting counter-indication to MRI exploration
• patient must not have received neither radiotherapy nor chemotherapy for that affection
• concomitant malignancy
• patient already enrolled in another biomedical study with an experimental molecule
• pregnant, nursing woman, or without contraception
• private individuals of freedom or under tutelage (including legal guardianship)
• psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiotherapy + temozolomide	radiotherapy	Radiotherapy: dose given at PTV-g will be 70 Gy/28 fractions level 1 75 Gy/30 fractions level 2 80 Gy/32 fractions level 3 dose given at PTV-a will be 56 Gy/28 fractions level 1 60 Gy/30 fractions level 2 60.8 Gy/32 fractions level 3 Chemotherapy: temozolomide given at the dose of 75mg/m2
radiotherapy + temozolomide	temozolomide	Radiotherapy: dose given at PTV-g will be 70 Gy/28 fractions level 1 75 Gy/30 fractions level 2 80 Gy/32 fractions level 3 dose given at PTV-a will be 56 Gy/28 fractions level 1 60 Gy/30 fractions level 2 60.8 Gy/32 fractions level 3 Chemotherapy: temozolomide given at the dose of 75mg/m2

Primary Outcome Measures

Name	Time	Method
To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma	3 months after the start of the radiotherapy

Trial Locations

Locations (1)

Centre Georges François Leclerc; 🇫🇷 Dijon, Bourgogne, France