Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00943462

Collaborator

Schering-Plough (Industry)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Astrocytoma, Grade IV Giant Cell Glioblastoma Glioblastoma Multiforme	Radiation: External-beam radiation therapy Drug: Temozolomide

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Use of PET/CT Imaging With 18F-fluoroethylcholine (FEC) in the Evaluation of Patients Treated With Radiotherapy and Temozolomide Following a Diagnosis of Glioblastoma Multiforme

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 therapy 60 Gy of external beam radiotherapy using a standard technique will be administered in 2-Gy fractions, for a total of 30 fractions Drug: Temozolomide 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).

Arm

Intervention/Treatment

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 therapy

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

Drug: Temozolomide

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).

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)
Schering-Plough

Investigators

Principal Investigator: Marie-Andrée Fortin, MD, Centre hospitalier de l'Université de Montréal (CHUM)

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Centre hospitalier de l'Université de Montréal (CHUM)

ClinicalTrials.gov Identifier:

NCT00943462

Other Study ID Numbers:

CE-08-234
Schering-P06046

First Posted:

Jul 22, 2009

Last Update Posted:

Jul 23, 2020

Last Verified:

Jul 1, 2020

Additional relevant MeSH terms:

Glioblastoma

Astrocytoma

Temozolomide

Study Results

No Results Posted as of Jul 23, 2020