This study is performed to investigate the optimal strategy for maintaining quality of life and improving survival in elderly patients (65 years or older) diagnosed with primary GBM. Primary endpoints of the study are: 1) Proportion of patients with…
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Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Overall survival (OS) at 12 months, defined as the time from diagnosis to
the death of the patient from any cause.
2) The difference in mean changes scores of physical functioning, as measured
with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6
weeks and 3 months after surgery compared to mean score on baseline.
Secondary outcome
1) Progression-free survival (PFS), defined as the time from diagnosis to
disease progression (increase in residual tumor volume of more than 25%, or
occurrence of a new tumor lesion with a volume greater than 0.175cm3), or
death. As according to the RANO criteria.
2) The difference in mean score of physical functioning, as measured with the
EORTC QLQ-C30 physical scale, between the two groups at 6 months and 12 months
after surgery compared to mean score on baseline.
3) The proportion of patients with deterioration, improvement or stable
physical functioning, as measured with the EORTC QLQ-C30 physical scale at 6
weeks, 3 months, 6 months and 12 months after surgery compared to baseline
4) Changes in the mean scores on the other health-related quality of life
(HRQoL) scales at 6 weeks, 3 months, 6 months and 12 months after surgery
compared to baseline scores. These HRQoL aspects will be measured using the
EORTC QLQ-C30, EORTC QLQ-BN20 and EQ-5D questionnaires.
5) Proportion of patients with NIHSS (National Institute of Health Stroke
Scale) deterioration, improvement or stability at 6 weeks, 3 months, 6 months
and 12 months after surgery compared to baseline, in which deterioration is
defined as an increase of at least one point and improvement as a decrease of
at least one point on the total NIHSS score compared to this score at baseline.
6) Differences between the groups in cognitive and neurolinguistic screening at
3 months, compared to baseline as measured by the Aphasia Bedside Check (ABC),
Shortened Token Test, verbal fluency (category and letter), Montreal Cognitive
Assessment (MOCA) and, optionally, CAT-NL Picture Description and Object Naming.
7) Comparison of the (S)AEs in both groups.
8) Cost-effectiveness between the two treatments.
Background summary
Glioblastoma Multiforme (GBM) is the most common glial tumor. The prognosis of
patients diagnosed with GBM remains poor, despite intensive treatments. No
objective guidelines or well-designed prospective trials exist regarding the
optimal surgical treatment of GBM, especially not in the elderly. The decision
for a certain type of surgery, e.g. resection surgery or tissue biopsy, is
usually subjective, as it is based on the experience of the surgeon. Due to
this, large differences in surgical management strategies exist between
neurosurgical centers. Retrospective literature elicits the importance of
maximum tumor resection to prolong survival of GBM patients, especially in
older patients. This is however exactly the subgroup of patients that is, with
the current subjective system, more likely to undergo a biopsy. Maximum safe
tumor resection could however be more beneficial for survival in this patient
category. On the other hand, surgery has the risk of inducing neurological
deficits and therefore the chance of seriously damaging the patient with a
rather low life expectancy.
Study objective
This study is performed to investigate the optimal strategy for maintaining
quality of life and improving survival in elderly patients (65 years or older)
diagnosed with primary GBM. Primary endpoints of the study are: 1) Proportion
of patients with NIHSS (National Institute of Health Stroke Scale)
deterioration at 6 weeks after surgery, in which deterioration is defined as an
increase of at least one point on the total NIHSS score compared to this score
at baseline 2) Overall survival (OS) at 12 months, defined as the time from
diagnosis to the death of the patient from any cause. Secondary endpoints are:
1) Progression-free survival (PFS) at 6 months and 12 months after surgery,
defined as the time from diagnosis to disease progression (increase in residual
tumor volume of more than 25%, or occurrence of a new tumor lesion with a
volume greater than 0.175cm3), or death 2) Health-related quality of life
(HRQoL) at 6 weeks, 3 months, 6 months and 12 months after surgery. HRQoL will
be measured using the QLQ-C30, QLQ-BN20 and EQ-5D questionnaires.
Study design
This trial is set up as a prospective randomized controlled trial. Patients who
are considered eligible for participation in the study based on clinical and
radiological parameters will be randomized into either biopsy or maximum safe
tumor resection, after written informed consent has been obtained. Patients in
whom the diagnosis GBM is not confirmed in histological analyses will be
excluded from the study. After surgery, patients will receive standard adjuvant
treatment with concomitant Temozolomide and radiation therapy, and standard
follow-up. Total study duration will be 4 years, of which 3 years will comprise
patient inclusion, with a follow-up duration of 1 year.
Intervention
Biopsy versus maximum safe tumor resection.
Study burden and risks
Patients theoretically eligible for GBM resection or biopsy will be included.
Through shared-decision making patients and their treating physicians will
decide upon resection or biopsy. No alterations will be made to the standard
care, since both surgical modalities are widely used, so there will be no added
risk associated with participation.
Three quality of life questionnaires and 1 neurological examination will take
place preoperatively and 6 weeks, 3 months, 6 months and 12 months after the
surgery. Neuro-linguistic and cognitive testing will take place only
pre-operatively and once at 3 months postoperatively. The burden of this trial
for the patient is therefore confined.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Age >=70 years
2. Tumor diagnosed as glioblastoma on MRI with distinct ring-like pattern of
contrast enhancement with thick irregular walls and a core area reduced signal
suggestive of tumor necrosis as assessed by the surgeon.
3. Karnofsky Performance Score (KPS) >=70
4. Written Informed consent
Exclusion criteria
1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas
with malignant transformation
4. Medical reasons precluding MRI (e.g. pacemaker)
5. Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
6. Severe aphasia prohibiting neurolinguistic testing and comprehension of
informed consent
7. Previous brain tumor surgery
8. Previous low-grade glioma
9. Second primary malignancy within the past 5 years with the exception of
adequately treated in situ carcinoma of any organ or basal cell carcinoma of
the skin.
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 | NL74339.078.20 |