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Completed

NCT Number: NCT01043536

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Georges François Leclerc

Dijon, Bourgogne-Franche-Comté, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Radiotherapy

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

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Collaborators

  • Ligue contre le cancer, France

Registry information

Official study title

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

Acronym: SIB-IMRT

Important dates

Study start
2009
Primary completion
2012
First posted
Jan 6, 2010
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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