Enhancing Optune Therapy With Targeted Craniectomy

This is an interventional treatment trial for Glioblastoma focused on measuring Tumour treating fields, Optune, Craniectomy, TTFields Read More

Inclusion Criteria:

• Pathological evidence of GBM using WHO classification criteria
• Estimated survival minimum three months
• Supratentorial tumor
• Not a candidate for further radiotherapy
• First disease recurrence in accordance with RANO criteria
• Karnofsky scale score minimum 70
• Ability to comply with Optune therapy
• Tumor characteristics which indicate significant expected benefit from feasible craniotomy or skull remodelling surgery combined with TTFields
• Focal tumor
• Most superficial border of tumor or resection cavity closer than 2 cm from brain surface
• Use of validated anti-conception for female participants in accordance with guidelines provided by the Danish Health and Medicines Authority
• Signed written consent form

Exclusion Criteria:

• Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy
• Less than four weeks since radiation therapy
• Infratentorial tumor
• Implanted pacemaker, programmable shunt, defibrillator, deep brain stimulator, other implanted devices in the brain, or documented clinically significant arrhythmias.
• Uncontrollable symptomatic epilepsy, refractory to standard medication. Epilepsy will not necessarily contraindicate participation in the trial as this is a common complication to the disease. Eligibility will be determined by the examining physician and investigators in conjunction upon careful consideration of patient safety.
• Contraindications for skull remodelling surgery, e.g. bleeding diathesis or severe infection.
• Significant co-morbidities (within four weeks prior to enrolment)
• Significant liver function impairment - ALT > 3 times the upper limit of normal
• Total bilirubin > upper limit of normal
• Significant renal impairment (serum creatinine > 1.7 mg/dL)
• Coagulopathy (as evidenced by PT or APTT > 1.5 times control in normal individuals not undergoing anticoagulation)
• Thrombocytopenia (platelet count < 100x10^3/μL )
• Anemia (Hb < 10 g/L)
• Active participation in another clinical treatment trial

Patients will be regarded as participants when they have signed a consent form and have been found suitable for enrolment by the examining physician, in accordance with the abovecriteria. Patients may receive medication depending on their clinical condition and other diseases.