The aim of this study if PET using [18F] fluorothymidine (FLT), an imaging biomarker, performed at week 10 of concomitant radio/chemotherapy for patients with newly diagnosed GBM is superior to MRI at 10 weeks to evaluate treatment response and to…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of FLT-PET treatment response defined as a more than 25% reduction
in standardized uptake values (SUV) max at week 10 after start to MRI response
at 22 and 34 weeks.
Secondary outcome
Correlation of FLT-PET response defined as a more than 25% reduction in
standardized uptake values (SUV) max at week 10 after start radio/chemotherapy
and OS at 6 months.
Background summary
First line treatment of patients with high grade brain tumours (glioblastoma
multiforme GBM) consists of treatment with combined radiotherapy with
chemotherapy (Temozolomide) after operation. This combination consists of 6
weeks of radiotherapy with daily oral intake of chemotherapy. After 4 weeks
rest an MRI scan is conducted (MRI 10 weeks). Treatment will be continued with
6 courses of chemotherapy only and additional MRI*s are performed after 3
courses (MRI week 22) and 6 courses (MRI 34 weeks) of chemotherapy.
The evaluation of the first MRI scan (MRI 10 weeks) is complex; beside the
tumour itself the scans show effects of surgery, radiation and chemotherapy.
Progressive and enhancing lesions on this MRI scan, which are not only related
to tumour progression, but which are a treatment effect is called
pseudoprogression. MRI*s performed at 22 and 34 weeks are less complex to
evaluate and correlate better with treatment response. This study investigates
if FLT-PET (FLT is an imaging biomarker for fast dividing cells) at 10 weeks
proves superior to MRI at 10 weeks, to evaluate patients with newly diagnosed
GBM treated with radio/chemotherapy. If FLT-PET proves superior this will lead
for future patients to stop treatment with no clinical benifit, or start with a
second line treatment.
Study objective
The aim of this study if PET using [18F] fluorothymidine (FLT), an imaging
biomarker, performed at week 10 of concomitant radio/chemotherapy for patients
with newly diagnosed GBM is superior to MRI at 10 weeks to evaluate treatment
response and to predict if continuation of additional chemotherapy is useful.
Study design
To assess the ability of FLT-PET at 10 weeks to evaluate the response of
combined radio/chemotherapy superior to MRI at 10 weeks in patients with newly
diagnosed GBM, FLT-PET within 1 week before the initiation of treatment, and
follow-up FLT-PET at 10 weeks after start of treatment and conventional MRI
before, at 10 and at 22 weeks, will be performed.
Study burden and risks
This trial uses FLT-PET. Radioactivity of fluor has a short half life of 110
minutes. The total FLT radiation used in this trial is 6.2 mSv, this is half
the amount of a normal CT scan.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• Patients with histologically confirmed newly diagnosed glioblastoma multiforme (World Health Organization [WHO] grade IV astrocytoma) with indication 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.
• Absence of inability to undergo MRI or PET scanning
• Patients >18 years of age
• WHO performance status of 2 or less
• 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
• Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
Are formulated as 'no existence of' in inclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26078.042.08 |