King's College NHS Foundation Trust
London, SE5 9RS, United Kingdom
NCT Number: NCT07384884
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
London, SE5 9RS, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will have combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.
Other names: laser interstitial thermal therapy
Time frame: 12 months
To assess post-operative neurocognitive function using the Montreal Cognitive Assessment
Time frame: 12 months
To evaluate progression-free survival
Time frame: 12 months
To assess quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assessment.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, and a high score for a symptom scale / item represents a high level of symptomatology / problems.
King's College Hospital NHS Trust
Other
Acronym: SLITT-GBM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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