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Device

Tumor Treating Fields + Chemoradiation for Glioblastoma

Phase 1
Waitlist Available
Led By Ricky Chen, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
GBM or Gliosarcoma by histology
KPS 70% or greater at time of entry to study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment for patients with glioblastoma. Eligible patients will receive a new therapy called tumor treating fields therapy using the Optune device in addition to standard radiation and chemotherapy.

Who is the study for?
This trial is for adults over 22 with newly diagnosed glioblastoma, a type of brain cancer, who've had surgery or biopsy and are expected to live at least 12 weeks. They must be able to follow the study plan and use birth control. People can't join if they've had certain prior treatments, significant liver issues, substance abuse problems within 3 years, psychiatric conditions affecting participation, specific medical devices implanted, or severe allergies.Check my eligibility
What is being tested?
The trial tests Tumor Treating Fields using the Optune device alongside standard chemoradiation therapy with temozolomide in patients after surgery for glioblastoma. It's an open-label pilot study where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Possible side effects include skin irritation under the device pads, headaches from wearing the device itself or from radiation therapy; nausea and fatigue due to chemotherapy; as well as potential blood disorders like low platelet counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with GBM or Gliosarcoma.
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I am mostly able to care for myself and carry out daily activities.
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I am 22 years old or older.
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My tumor is located in the upper part of my brain.
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I can only undergo a biopsy or a safe maximum tumor removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 24 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
Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy
Severity of Treatment-Related Adverse Events Associated With Trimodal Therapy
Secondary outcome measures
Overall Survival Rate
Progression-free Survival at 6 Months and 24 Months

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment3 Interventions
Patients will receive trimodal therapy consisting of tumor treating fields therapy with the Optune device concurrent with temozolomide and radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Temozolomide
FDA approved

Find a Location

Who is running the clinical trial?

NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,706 Total Patients Enrolled
28 Trials studying Glioblastoma
2,728 Patients Enrolled for Glioblastoma
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,528 Total Patients Enrolled
1 Trials studying Glioblastoma
11 Patients Enrolled for Glioblastoma
University of California, San FranciscoOTHER
2,500 Previous Clinical Trials
15,236,464 Total Patients Enrolled
21 Trials studying Glioblastoma
4,114 Patients Enrolled for Glioblastoma

Media Library

Optune (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03705351 — Phase 1
Glioblastoma Research Study Groups: Treatment
Glioblastoma Clinical Trial 2023: Optune Highlights & Side Effects. Trial Name: NCT03705351 — Phase 1
Optune (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03705351 — Phase 1

Frequently Asked Questions

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

Is there currently an opportunity to participate in this research study?

"This trial is not open for enrolment at the moment. It was initially listed on December 2nd 2019 and its latest update happened on April 11th 2021. For those who are seeking other research opportunities, 805 clinical trials that involve cancer of brain have been actively recruiting while 206 studies require Radiation Therapy subjects."

Answered by AI

What ailments can be treated with the use of Radiation Therapy?

"Radiation Therapy has proven to be an effective means of treating nitrosourea treatment, advance directives and refractory, advanced mycosis fungoides."

Answered by AI

To what extent can Radiation Therapy be utilized without risk to patients?

"Due to the limited clinical data available, Radiation Therapy was assigned a score of 1 on our safety scale. This trial is in its earliest phase and has yet to reveal any meaningful evidence for efficacy or safety."

Answered by AI

How many individuals have joined this clinical trial thus far?

"At this moment in time, no further patients are being sought for this trial. Initially posted on December 2nd 2019 and last amended on April 11th 2021, the study is not actively recruiting any more volunteers. However, there are 805 cancer of brain trials as well as 206 Radiation Therapy studies that presently need participants."

Answered by AI

What additional research exists concerning the effectiveness of Radiation Therapy?

"Currently, 206 live trials for Radiation Therapy are in progress and 23 of them have reached Phase 3. Although most tests take place in Seoul, Songpa there are over 4500 other medical centres offering this treatment to patients."

Answered by AI

Does this research trailblaze a new approach to treatment?

"Since 2002, Radiation Therapy has been a subject of study. This research was inaugurated by the pharmaceutical company Schering-Plough in an initial trial with 60 participants. Following approval from Phase 2 trials, there are now 206 active studies pertaining to this treatment hosted across 36 countries and 935 cities."

Answered by AI
~1 spots leftby Apr 2025