NCT01043536

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

January 5, 2010

Last Update Submit

September 24, 2012

Conditions

Glioblastoma

Keywords

IMRTRadiotherapy escalation doseglioblastomaescalation radiotherapy dose

Outcome Measures

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

    3 months after the start of the radiotherapy

Study Arms (1)

radiotherapy + temozolomide

EXPERIMENTAL

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: radiotherapyDrug: temozolomide

Interventions

radiotherapyRADIATION

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.

radiotherapy + temozolomide
temozolomideDRUG

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.

radiotherapy + temozolomide

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Georges François Leclerc

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

RadiotherapyTemozolomide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TherapeuticsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gilles Truc, MD

    Centre Georges François Leclerc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2012

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

FR(1)