Astrocytoma, Grade IVNCT00943462
Study of 18F-FEC for Positron Emission Tomography-Computed Tomography (PET-CT) Imaging of GBM
An observational study of Astrocytoma, Grade IV and Giant Cell Glioblastoma, run by Centre hospitalier de l'Université de Montréal (CHUM).
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- External-beam radiation therapy and Temozolomide
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GBM patients seen at the neuro-oncology clinic of Centre hospitalier de l'Université de Montréal (CHUM)
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
About this study
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
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.
- Being tested
- External-beam radiation therapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: External-beam radiation therapy; Drug: Temozolomide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: No eligible patients could be recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Astrocytoma, Grade IVStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Marie-Andrée Fortin, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943462
- Sponsor's protocol ID
- CE-08-234
- Other IDs
- Schering-P06046
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2009
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19269895
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00943462
- Acronym / sponsor ID
- CE-08-234
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No eligible patients could be recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma Multiforme (GBM) | – | Radiation: External-beam radiation therapy, Drug: TemozolomideWe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GBM patients seen at the neuro-oncology clinic of Centre hospitalier de l'Université de Montréal (CHUM)
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External-beam radiation therapy60 Gy of external beam radiotherapy using a standard technique will be administered in 2-Gy fractions, for a total of 30 fractions | Radiation | Glioblastoma Multiforme (GBM) |
| TemozolomideThe 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). | Drug | Glioblastoma Multiforme (GBM) |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 19269895Stupp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Andrée Fortin, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Questions about this trial
What is this clinical trial studying?
An observational study of Astrocytoma, Grade IV and Giant Cell Glioblastoma, run by Centre hospitalier de l'Université de Montréal (CHUM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.