In preparation of a randomized controlled trial, we aim to assess pilot data on technical feasibility and safety of LITT and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma, as compared with…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main goal of the study is to assess technical feasibility and safety of
LITT at our center and to assess practical feasibility of a future multicentre
randomized controlled trial with the same design. Safety and technical
feasibility will be assessed by an expert committee, consisting of head of
department, independent expert and project leader.
To assess safety, the following endpoints will be considered:
- 30-days mortality
- Complications Clavien Dindo >/= 3
The procedure will be deemed feasible when:
- Time from inclusion to procedure
- Time from LITT to adjuvant therapy
- Surgical procedure duration between 4-8 h, comparable to a standard
craniotomy for tumour resection
- Ablation of 90% of the target lesion in at least 70% of patients
To assess practical feasibility of a future larger randomized trial, the
following parameters will be considered:
- Inclusion rate of patients meeting the inclusion criteria
- Withdrawal / drop-out within 30 days
- Completed follow-up at 3 months
Secondary outcome
Secondary endpoints of the study are:
- Overall and progression-free survival (OS, PFS) at 3 months after treatment
and change in quality of life (QoL) before and 3 months after treatment will be
recorded and used to implement power analysis of a future randomized trial. No
comparative statistical analysis will be performed in this pilot study on OS,
PFS and QoL given the small amount of patients included.
- Tumour volume evolution on pre-operative, post-procedure and 3 months
post-operative MRI.
- Learning curve (measured as evolution of duration of the intervention,
ablation percentage and complications).
Background summary
Laser interstitial thermal therapy (LITT) has recently demonstrated its role as
a safe and minimally invasive procedure in the treatment of brain tumours.
Several studies show the application of LITT in newly diagnosed and recurrent
glioblastoma, in radiotherapy and chemotherapy resistant metastases or in
tumours in difficult accessible locations, with promising initial results. Due
to limited follow-up and early experiences, there is currently no high-quality
prospective evidence comparing LITT with standard of care, precluding any
conclusions on cost-effectiveness of LITT.
Study objective
In preparation of a randomized controlled trial, we aim to assess pilot data on
technical feasibility and safety of LITT and to assess practical feasibility of
a randomized study in patients with primary irresectable glioblastoma, as
compared with standard of care.
Study design
Prospective randomized pilot study.
Intervention
Patients will be randomized to receive either (i) biopsy and LITT (n=10) or
(ii) biopsy only (n=10).
Study burden and risks
We hypothesize that LITT provides patients with an irresectable glioblastoma a
relevant survival benefit with maximal retainment of quality of life at minimal
morbidity and fast recovery. LITT has been shown to carry limited risk of
post-operative complications, mostly reversible. The main risks associated to
the procedure are bleeding, brain edema, neurological deterioration, operation
site infection, epilepsy. Included patients will undergo cerebral follow-up
MRI*s, following the same scanning protocol as currently used (before and 3
months after surgery). Patients will be requested to fill in two quality of
life questionnaires (EQ-5D and EORTC QLQ - BN20) pre-operatively and 3 months
after surgery.
All adverse events will be monitored.
Geert Grooteplein Zuid 10
nijmegen 6524 ga
NL
Geert Grooteplein Zuid 10
nijmegen 6524 ga
NL
Listed location countries
Age
Inclusion criteria
- Informed consent, age >18-year-old
- Supratentorial localization
- Maximal volume <=70cc on post-contrast T1 MRI
- Safe trajectory/trajectories possible for ablation of at least 70% of the
tumour, avoiding eloquent structures or transgression of a ventricle or vessel.
- Karnofsky Performance Status (KPS) >= 70
Exclusion criteria
- Contra-indication for general anaesthesia or MRI
- Lesion >70cc on post-contrast MRI on the day before intervention.
- Non-glioblastoma diagnosis as per frozen section analysis
- Pregnancy
Design
Recruitment
Medical products/devices used
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 | NL73896.091.20 |