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

NCT ID: NCT01043536

Last Updated: 2012-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30

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.

Conditions

Glioblastoma

Keywords

IMRT; Radiotherapy escalation dose; glioblastoma; escalation radiotherapy dose

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy + 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

Group Type: EXPERIMENTAL

radiotherapy

Intervention Type: RADIATION

patients will receive from 6 to 7 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.

temozolomide

Intervention Type: DRUG

patient will receive whatever the level 7 days a week, temozolomide at the dose of 75mg/m2 during radiotherapy period. They will then follow one month after the end the radiochemotherapy an adjuvant treatment corresponding to a 5 days treatments of temozolomide at the dose of 200mg/m2 every 28 days.

Interventions

radiotherapy

patients will receive from 6 to 7 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.

Intervention Type: RADIATION

temozolomide

patient will receive whatever the level 7 days a week, temozolomide at the dose of 75mg/m2 during radiotherapy period. They will then follow one month after the end the radiochemotherapy an adjuvant treatment corresponding to a 5 days treatments of temozolomide at the dose of 200mg/m2 every 28 days.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ligue contre le cancer, France

OTHER

Sponsor Role: collaborator

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Truc, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Georges François Leclerc

Locations

Centre Georges François Leclerc

Dijon, Bourgogne-Franche-Comté, France

Countries

France

Other Identifiers

0244-1blni08 / 009.020

Identifier Type: -

Identifier Source: org_study_id