Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02893137 : Enhancing Optune Therapy With Targeted Craniectomy
PhasePhase 1
AgesMin: 18 Years Max: N/A
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

- 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

- 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.
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