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


Phase 1
18 Years
70 Years
Not Enrolling
Both
Glioblastoma

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma

Outcome Time Frame:

3 months after the start of the radiotherapy

Safety Issue:

Yes

Principal Investigator

Gilles Truc, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Georges François Leclerc

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0244-1blni08 / 009.020

NCT ID:

NCT01043536

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Glioblastoma
  • IMRT
  • Radiotherapy escalation dose
  • glioblastoma
  • escalation radiotherapy dose
  • Glioblastoma

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