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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01043536
First Posted: January 6, 2010
Last Update Posted: September 25, 2012
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.
Collaborator:
Ligue contre le cancer, France
Information provided by (Responsible Party):
Centre Georges Francois Leclerc
  Purpose
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 Intervention Phase
Glioblastoma Radiation: radiotherapy Drug: temozolomide Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Georges Francois Leclerc:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: September 2009
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01043536


Locations
France
Centre Georges François Leclerc
Dijon, Bourgogne, France, 21000
Sponsors and Collaborators
Centre Georges Francois Leclerc
Ligue contre le cancer, France
Investigators
Principal Investigator: Gilles Truc, MD Centre Georges François Leclerc
  More Information

Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT01043536     History of Changes
Other Study ID Numbers: 0244-1blni08 / 009.020
First Submitted: January 5, 2010
First Posted: January 6, 2010
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Centre Georges Francois Leclerc:
IMRT
Radiotherapy escalation dose
glioblastoma
escalation radiotherapy dose

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents