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

Centre Georges Francois Leclerc

Status and phase: Completed; Phase 1

Conditions: Glioblastoma

Treatments: Radiation: radiotherapy; Drug: temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01043536

0244-1blni08 / 009.020

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

radiotherapy + temozolomide

Experimental group

Description:

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

Treatment:

Drug: temozolomide

Radiation: radiotherapy