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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00943462
• Other study ID #: CE-08-234
• Secondary ID: Schering-P06046
• Status: Withdrawn
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2020
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Astrocytoma
• Astrocytoma, Grade IV
• Giant Cell Glioblastoma
• Glioblastoma
• Glioblastoma Multiforme

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & 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. — View Citation