Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKing's College Hospital NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

bGBM measuring >2.5 cm in both hemispheres.

Tumour progression between surgical debulking and LITT treatment

Severe complications after surgery (hydrocephalus, infection, heamatoma, stroke)

Trial design

Design model

Single group

Treatments tested in this trial

  • surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

    Procedure/Surgery

    All patients will have combined unilateral open surgery for maximal tumour resection followed by contralateral LITT to the smaller component/residual.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Surgical resection followed by LITTOther 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of Neurocognitive Function

To assess post-operative neurocognitive function using the Montreal Cognitive Assessment

Time frame
12 months

Secondary outcomes

1

Progression-free survival in years

To evaluate progression-free survival

Time frame
12 months
2

Assessing Quality of Life

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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