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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01043536
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre Georges Francois Leclerc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Gilles Truc, MD
Principal Investigator Affiliation Centre Georges François Leclerc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

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

Interventions

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.

Contact a Trial Team

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International Sites

Centre Georges François Leclerc, Dijon, Bourgogne, France

Status

Address

Centre Georges François Leclerc

Dijon, Bourgogne, 21000

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