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Phase II study of 18F fluorothymidine positron emmission tomography (FLTPET) in the follow up of glioblastoma multiforme patients treated with combined radiotherapy and chemotherapy.


- candidate number13485
- NTR NumberNTR3680
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-okt-2012
- Secondary IDs200.83.45 METC UMCG
- Public TitlePhase II study of 18F fluorothymidine positron emmission tomography (FLTPET) in the follow up of glioblastoma multiforme patients treated with combined radiotherapy and chemotherapy.
- Scientific TitleFLT PET in newly diagnosed GBM
- ACRONYMFLTGBM
- hypothesisThe aim of this study is to assess the ability of PET using [18F] fluorothymidine (FLT), an imaging biomarker, performed at week 10 of treatment can discriminate between pseudo progression and true progression as measured by MRI at 10 and 22 weeks, in patients with newly diagnosed GBM treated with concomitant and adjuvant chemoradiotherapy with temozolomide.
- Healt Condition(s) or Problem(s) studiedBrain tumor, Glioblastoma multiforme
- Inclusion criteria1. Patients with histologically confirmed newly diagnosed glioblastoma multiforme (World Health Organization [WHO] grade IV astrocytoma) with indication and eligibility for radiotherapy and concomitant TMZ followed by adjuvant TMZ. Patients must have clinically and radiographically documented measurable disease. Conventional MRI post surgery must be performed within 28 days prior to start of combined treatment;
2. Absence of inability to undergo MRI or PET scanning;
3. Patients >18 years of age;
4. WHO performance status of 2 or less;
5. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
6. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Exclusion criteria1. Patients with no histologically confirmed newly diagnosed glioblastoma multiforme (World Health Organization [WHO] grade IV astrocytoma) or without indication and eligibility for radiotherapy and concomitant TMZ followed by adjuvant TMZ. No conventional MRI post surgery;
2. Inability to undergo MRI or PET scanning;
3. Patients <18 years of age;
4. WHO performance status of 3;
5. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
6. No written informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 2-dec-2009
- planned closingdate2-dec-2013
- Target number of participants30
- InterventionsTo assess the ability of FLT-PET to discriminate between pseudo progression and true progression as measured by MRI at 10 and 22 weeks in patients with newly diagnosed GBM treated with concomitant and adjuvant chemoradiotherapy with temozolomide.
Baseline FLT-PET within 1 week before the initiation of treatment, and follow-up FLTPET at 10 weeks after start of treatment and conventional MRI before, at 10 and at 22 weeks, will be assessed. For secondary endpoints OS at 6 and 12 months, immunohistochemical staining for Ki-67 on tumor and MRI within 1 week before the initiation of treatment, and follow-up MRI at 10 and 22 weeks will be performed.
- Primary outcomeComparison of FLT-PET response defined as a more than 25% reduction in standardized uptake values (SUV) max (see section 7) at week 10 after start temozolomide/radiotherapy to MRI response at 22 weeks between pseudo progression and true progression.
- Secondary outcome1. Correlation of FLT-PET response defined as a more than 25% reduction in standardized uptake values (SUV) max (see section 7) at week 10 after start temozolomide/radiotherapy and OS at 6 and 12 months;
2. Correlation of Ki-67 proliferation index on tumor obtained by immunohistochemical staining with FLT SUV max uptake.
- TimepointsTo assess the ability of FLT-PET to discriminate between pseudo progression and true progression as measured by MRI at 10 and 22 weeks in patients with newly diagnosed GBM treated with concomitant and adjuvant chemoradiotherapy with temozolomide baseline FLT-PET within 1 week before the initiation of treatment, and follow-up FLTPET at 10 weeks after start of treatment and conventional MRI before, at 10 and at 22 weeks, will be assessed. For secondary endpoints OS at 6 and 12 months, immunohistochemical staining for Ki-67 on tumor and MRI within 1 week before the initiation of treatment, and follow-up MRI at 10 and 22 weeks will be performed.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. A.M.E. Walenkamp
- CONTACT for SCIENTIFIC QUERIESDr. A.M.E. Walenkamp
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThe aim of this study is to assess the ability of PET using [18F] fluorothymidine (FLT), an imaging biomarker, performed at week 10 of treatment can discriminate between pseudo progression and true progression as measured by MRI at 10 and 22 weeks, in patients with newly diagnosed GBM treated with concomitant and adjuvant chemoradiotherapy with temozolomide.
- Main changes (audit trail)
- RECORD26-okt-2012 - 12-okt-2013


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