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

NCT02397928 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2018-09-25

No results posted yet for this study

Summary

The study is a prospective, single arm, non-randomized, open label phase II trial, designed to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

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.

Sponsors & Collaborators

  • NovoCure Ltd.

    lead INDUSTRY

Principal Investigators

  • Giovanni Luca Ceresoli, MD · Cliniche Humanitas Gavazzeni

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397928 on ClinicalTrials.gov