To prospectively evaluate the (cost)-effectiveness of LITT plus chemoradiation therapy (CRT) vs. CRT alone in patients with primary irresectable glioblastoma (GBM).
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are overall survival (OS) and quality-of-life (QoL) using
QLQ-C30+BN20 questionnaire.
Secondary outcome
Secondary endpoints are disease-specific and progression-free survival (PFS),
generic QoL using EQ5D-5L, complication rates, tumor volume response, effects
on adjuvant treatment and costs.
Background summary
Laser interstitial thermal therapy (LITT) is recently growing as a 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. After conducting a pilot study at Radboudumc to
study safety and feasibility of LITT in patients with an irresectable
glioblastoma, we propose a larger nation-wide multicenter randomized controlled
study to evaluate cost-effectiveness of this technique.
Study objective
To prospectively evaluate the (cost)-effectiveness of LITT plus chemoradiation
therapy (CRT) vs. CRT alone in patients with primary irresectable glioblastoma
(GBM).
Study design
Multicenter nation-wide randomized controlled trial.
Intervention
Patients will be randomized to receive either (i) biopsy and LITT, followed by
standard CRT or (ii) biopsy alone, followed by standard CRT.
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, minimal
morbidity and fast recovery. LITT has been shown to carry limited risk of
post-operative complications, mostly reversible (5-26%). The main risks
associated to the procedure are bleeding, brain edema, neurological
deterioration, operation site infection, epilepsy. We recently conducted a
pilot study at Radboudumc and the results showed the procedure to be safe and
feasible. Patients will be followed for minimum 18 months, up to a maximum of
64 months over the entire study period..
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
- Safe trajectory/trajectories possible for ablation of at least 70% of the
tumour, avoiding eloquent structures.
- Karnofsky Performance Status (KPS) >= 70
Exclusion criteria
- Contra-indication for general anaesthesia or MRI
- Non-glioblastoma diagnosis on pathology analysis
- No final pathology diagnosis available
- 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 | NL79202.091.21 |