NCT00943462

Brief Summary

Positron Emission Tomography-Computed Tomography (PET-CT) with injection of 18F-fluoroethylcholine (FEC) could be a useful tool in the evaluation and follow-up of patients who have been diagnosed with glioblastoma multiforme (GBM) and who are treated with radiotherapy and temozolomide by allowing, for example, the distinction of necrosis from tumour tissue. This tool could help the clinician in making therapeutic decisions for GBM patients.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Status
withdrawn

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

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 20, 2009

Last Update Submit

July 21, 2020

Conditions

Astrocytoma, Grade IVGiant Cell GlioblastomaGlioblastoma Multiforme

Study Arms (1)

Glioblastoma Multiforme (GBM)

We will conduct a prospective study on 20 consecutive patients who are seen at the Hôpital Notre-Dame neuro-oncology clinic for a diagnosis of GBM and who meet our inclusion criteria. We will meet with the eligible patients in order to provide them with a detailed description of the study procedures as well as to have them sign a consent form.

Radiation: External-beam radiation therapyDrug: Temozolomide

Interventions

External-beam radiation therapyRADIATION

60 Gy of external beam radiotherapy using a standard technique will be administered in 2-Gy fractions, for a total of 30 fractions

Glioblastoma Multiforme (GBM)
TemozolomideDRUG

The chemotherapy will have to be administered in accordance with the protocol used in the CAN-NCIC-CE3 study, which established the current standard for treatment of GBM with the administration of temozolomide as adjuvant therapy at the same time as radiotherapy (clinicaltrials.gov ID NCT00006353).

Glioblastoma Multiforme (GBM)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

GBM patients seen at the neuro-oncology clinic of Centre hospitalier de l'Université de Montréal (CHUM)

You may qualify if:

  • Age between 18 and 70 years of age
  • Histological diagnosis of GBM (grade IV astrocytoma based on the World Health Organization \[WHO\] classification)
  • No previous radiotherapy or chemotherapy
  • No history of previous neoplasms
  • Inoperable patients (tumour in place, biopsy only)
  • KPS ≥ 70
  • Adequate hematological, renal and hepatic function
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelets ≥ 100,000 per mm3
  • Serum creatinine ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
  • Total bilirubin ≤ 1.5 times the upper limit of normal of the laboratory where it is measured
  • Liver enzymes \< 3 times the upper limit of normal of the laboratory where they are measured
  • Patients under corticosteroids must have received a stable or decreasing dose in the 14 days preceding randomization
  • Consent form signed by the patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.

    PMID: 19269895BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marie-Andrée Fortin, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 22, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 23, 2020

Record last verified: 2020-07