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Device

TTFields + SRS + Temozolomide for Glioblastoma

Phase 1

Recruiting

Led By Scott G Soltys

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Platelet count ≥ 100 × 109/L without blood transfusions for 7 days preceding the lab assessment

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

Study Summary

This trial is testing a new combination therapy for newly diagnosed glioblastoma (GBM). The safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) will be determined.

Who is the study for?

Adults diagnosed with newly confirmed glioblastoma, able to undergo MRI, and have good organ function. Participants must not be pregnant or nursing, should not have other severe illnesses or skin conditions that could interfere with treatment, and cannot be on certain medications like those for tuberculosis or HIV.Check my eligibility

What is being tested?

The trial is testing a combination therapy for brain cancer (glioblastoma) using Tumor Treating Fields (TTFields), Stereotactic radiosurgery (SRS), and the chemotherapy drug Temozolomide to evaluate safety and effectiveness.See study design

What are the potential side effects?

Possible side effects include skin irritation from TTFields device adhesives, fatigue from radiotherapy, nausea from chemotherapy, potential liver enzyme changes due to medication interactions, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My platelet count is healthy without needing blood transfusions in the past week.

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I am 18 years old or older.

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I have been newly diagnosed with glioblastoma or its molecular equivalent.

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My white blood cell count is healthy without needing medication for the past week.

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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting Toxicity (DLTs)

Secondary outcome measures

Acute dose limiting toxicity

Overall Survival (OS)

Progression-free Survival (PFS) at 6 Months

Trial Design

1Treatment groups

Experimental Treatment

Group I: Novo-TTFExperimental Treatment4 Interventions

Day 1: Subjects will wear the Optune (TTFields device) for ≥ 18 hours/day. They will take off the device when receiving stereotactic radiosurgery and brain MRI scans. Days 1 to 8: Subjects will take oral temozolomide 75 mg/m2/day Days 2 to 8: Subjects will receive stereotactic radiosurgery (total of 35 Gy) divided equally over 5 days • After the interventional treatment, subjects will receive standard of care adjuvant chemotherapy and routine surveillance brain MRI scans.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Optune

2016

Completed Phase 1

~90

Gadolinium

2006

Completed Phase 4

~620

Temozolomide

2010

Completed Phase 3

~1930

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,343 Total Patients Enrolled

4 Trials studying Glioblastoma

398 Patients Enrolled for Glioblastoma

NovoCure Ltd.Industry Sponsor

57 Previous Clinical Trials

4,720 Total Patients Enrolled

28 Trials studying Glioblastoma

2,742 Patients Enrolled for Glioblastoma

Scott G SoltysPrincipal InvestigatorStanford Universiy

Media Library

Optune (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04474353 — Phase 1

Glioblastoma Research Study Groups: Novo-TTF

Glioblastoma Clinical Trial 2023: Optune Highlights & Side Effects. Trial Name: NCT04474353 — Phase 1

Optune (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04474353 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior research has been done on the effectiveness of Stereotactic radiosurgery (SRS)?

"At present, 215 medical trials are underway exploring Stereotactic radiosurgery (SRS), with 23 of those in the third phase. While Seoul, Songpa is home to most investigations into this technique, there are 4777 other sites running studies regarding SRS across the globe."

Answered by AI

Are any new participants eligible to join this research endeavor?

"Affirmative. Patients are currently being recruited for this clinical trial, details of which were initially posted on the 21st of May 2021 and recently updated on August 17th 2022."

Answered by AI

To what maladies has Stereotactic radiosurgery (SRS) been clinically demonstrated to be efficacious?

"When dealing with nitrosourea treatment, advance directives and refractory advanced mycosis fungoides, Stereotactic Radiosurgery (SRS) can be employed as an efficacious therapeutic approach."

Answered by AI

Has the government approved of Stereotactic Radiosurgery (SRS) for public use?

"SRS is still in its early stages of research, so it has been assigned a score of 1. This reflects the limited evidence available on this treatment's safety and efficacy."

Answered by AI

What is the scale of enrollment for this research initiative?

"Affirmative. The clinical trial is still recruiting, as indicated on its page hosted on clinicaltrials.gov. It was initially posted on May 21st 2021 and the last update was August 17th 2022; 12 volunteers are being sought out from a single medical centre."

Answered by AI

Is this research endeavor pioneering in its approach?

"Globally, there are 36 countries with 940 cities encompassing 215 active clinical trials regarding Stereotactic Radiosurgery (SRS). The first trial of its kind was conducted in 2002 by Schering-Plough. This study featured 60 patients and achieved Phase 2 drug approval. Since then, 315 more studies have been completed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma

2021. "Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04474353.

All > Recurrent Glioblastoma > Glioblastoma Multiforme