Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, 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
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02893137      |      Link to official Clinicaltrials.gov listing
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