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

Glioblastoma Clinical Trial

— SIB-IMRT  

Official title:

Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043536
• Other study ID #: 0244-1blni08 / 009.020
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2010
• Last updated: September 24, 2012
• Start date: September 2009

Study information

• Verified date: September 2012
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Radiation:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon	Bourgogne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes