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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043536
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : September 25, 2012
Ligue contre le cancer, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Radiation: radiotherapy Drug: temozolomide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma
Study Start Date : September 2009
Actual Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: radiotherapy + temozolomide


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


temozolomide given at the dose of 75mg/m2

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.

Primary Outcome Measures :
  1. To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma [ Time Frame: 3 months after the start of the radiotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01043536

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Centre Georges François Leclerc
Dijon, Bourgogne, France, 21000
Sponsors and Collaborators
Centre Georges Francois Leclerc
Ligue contre le cancer, France
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Principal Investigator: Gilles Truc, MD Centre Georges François Leclerc
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Responsible Party: Centre Georges Francois Leclerc Identifier: NCT01043536    
Other Study ID Numbers: 0244-1blni08 / 009.020
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012
Keywords provided by Centre Georges Francois Leclerc:
Radiotherapy escalation dose
escalation radiotherapy dose
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents