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NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma

NCT03232424 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-11-18

No results posted yet for this study

Summary

This study is a prospective single arm trial designed to study the safety, feasibility and preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard adjuvant treatment for newly diagnosed glioblastoma.

Conditions

  • Glioblastoma, Adult

Interventions

DEVICE

NovoTTF-200A

* Begins the day prior to radiotherapy start and continues until the end of temozolomide maintenance cycle #2 or until evidence of disease progression or unacceptable toxicity. * Arrays are removed immediately prior to radiotherapy and replaced immediately thereafter.

DRUG

Temozolomide

Concomitant phase: * 75 mg/m2 per day for 42 days concomitant with radiotherapy. * Begins 1 day prior to XRT start. Maintenance phase: * Begins 4 weeks after concomitant phase completion (+/- 1 week). * Each cycle is 28 days (5 days of drug treatment followed by 23 days without). * Cycle 1: 150 mg/m2 once daily for the first 5 days of each treatment cycle. * Subsequent cycles: daily dose increased to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.

RADIATION

3D conformal or intensity modulated radiation therapy (IMRT)

Radiotherapy will commence 4 weeks after the definitive surgical procedure (+/- 1 week), to a total dose of 54.0 - 60.0 Gy, delivered in 1.8 - 2.0 Gy fractions over 6 - 7 weeks. XRT target volumes will be determined utilizing all available imaging studies that best delineate extent of disease. Fusion image registration for treatment planning will be utilized as possible. Either 3D conformal or intensity modulated radiation therapy (IMRT) will be utilized.

Sponsors & Collaborators

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Samuel Goldlust, MD · Hackensack Meridian Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2022-12-07
Completion
2022-12-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03232424 on ClinicalTrials.gov