Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR)

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Malignant Pleural Mesothelioma
Interventions
DEVICE

NovoTTF-100L device

Patients will be treated continuously with the NovoTTF-100L device. NovoTTF-100L treatment will consist of wearing four electrically insulated electrode arrays on the thorax. The treatment enables the patient to maintain regular daily routine.

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on day 1 of a 21-day cycle.

DRUG

Cisplatin or Carboplatin

Cisplatin 75 mg/m2 or carboplatin AUC 5 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end on the pemetrexed infusion on day 1 of a 21-day cycle.

Trial Locations (13)

Unknown

Antwerp University Hospital, Thoracic Oncology, Antwerp

Goustave Roussy - Cancer Campus Grand Paris, Villejuif

Universitätsklinikum Halle (Saale), Halle

"A.S.O. SS Antonio e Biagio e Cesare Arrigo", Alessandria

Cliniche Humanitas Gavazzeni, Bergamo

Ospedale Villa Scassi, Genoa

Ospedaliera di Perugia, Perugia

Ospedaliero Universitaria Pisana, Pisa

Erasmus Mc, Rotterdam

Medical University Gdansk, Gdansk

Katedra i Klinika Onkologii Uniwersytetu Medycznegi im. Karola Marcinkowskiego w Poznaniu, Poznan

Klinika Nowotworów Pluca I Klatki Piersiowej, Warsaw

Vall d' Hebron Institute of Oncology (VHIO) Hospital Vall d'Hebron, Barcelona

All Listed Sponsors
lead

NovoCure Ltd.

INDUSTRY

NCT02397928 - Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) | Biotech Hunter | Biotech Hunter