Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines.
- Who it may be relevant to
- Registry conditions: Brain Tumours, GBM. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Butterfly glioblastomas (bGBM), defined as tumours crossing the midline to involve hemispheres bilaterally, have a dismal prognosis with a median survival of 3.3-6 months and only 9% of patients with bGBM survive 2-years. These figures put bGBM in the worst end of the spectrum of GBM prognosis, significantly inferior to the survival figures quoted in the literature with standard of care - 14.6 months - particularly when 5-aminolevulinic acid is used as surgical adjuvant - 17.47 months. Despite the poor outcome of this disease, there is preliminary evidence suggesting that active oncology treatment can impact the survival of patients with this condition.With particular regards to surgical resection versus biopsy, there is a suggestion that resection improves overall survival at 6 months with no clear difference at 12 and 18 months of follow up. Laser-induced thermal therapy (LITT) is a minimally invasive laser ablation technique used in a range of brain tumours, including glioblastomas, with similar overall survival to the ones reported for open surgery in patients with lesions not amenable to open resection. The minimally invasive nature of this technique, significantly reducing the collateral damage to the surrounding brain structures, suggests Its potential in the treatment of this bGBM \[14\] with significant implications as a deficit-sparing technique, particularly if associated with preoperative and intraoperative monitoring and mapping techniques. The SLITT-GBM study will combine unilateral open surgery for maximal tumour resection with contralateral LITT to the smaller component/residual.
Interventions
- Procedure surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
All patients will have combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.
Primary outcome measures
- Assessment of Neurocognitive Function [Time frame: 12 months]
Secondary outcome measures (2)
- Progression-free survival in years [Time frame: 12 months]
- Assessing Quality of Life [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Presumptive diagnosis of bGBM as per preoperative MRI and MDT assessment
- Presumed residual / smaller component of the bGBM has to be < 2.5cm
- Performance Status 0-1
- Able to consent for the study
Exclusion criteria
- bGBM measuring >2.5 cm in both hemispheres.
- Tumour progression between surgical debulking and LITT treatment
- Severe complications after surgery (hydrocephalus, infection, heamatoma, stroke)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- King's College NHS Foundation Trust — London
Identifiers
NCT: NCT07384884 · 359416