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Brachytherapy

TheraSphere for Recurrent Brain Cancer (FRONTIER Trial)

Q: What is the upper limit for individuals participating in this trial?

This trial necessitates the participation of 12 eligible individuals. Those interested can join from Mayo Jacksonville in <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> or Northwestern Univerity in <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>.

Q: Are participants currently being accepted for this clinical investigation?

Yes, current data from clinicaltrials.gov confirms that this research project is looking to recruit 12 individuals at five locations. It was first uploaded on July 30th 2022 and was recently updated on November 8th 2022.

Q: How many health care centers are currently conducting this research project?

This scientific study is currently recruiting from 5 different sites; Jacksonville, Chicago and San Francisco are among them. To reduce travel overhead when enrolling in the trial, it can be beneficial to select a centre close by.

Phase < 1

Recruiting

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

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

Must have

Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria

Prior cranial radiation dose < 66 Gy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment through 6 months post index procedure

Awards & highlights

FRONTIER Trial Summary

This trial is testing a new way to treat recurrent brain cancer that is less invasive and has fewer side effects than current methods.

Who is the study for?

This trial is for adults over 18 with recurrent glioblastoma who've had prior treatment but not more than one round of radiotherapy or two surgeries. They must have adequate organ function, a life expectancy of at least 12 weeks, and be able to follow the trial procedures. Pregnant women can't participate, and those who can bear children must use birth control.Check my eligibility

What is being tested?

The FRONTIER Study is testing TheraSphere GBM's safety and feasibility in patients with recurrent glioblastoma. It's an interventional study where participants receive this device to see if it's safe and technically possible to use as a treatment option.See study design

What are the potential side effects?

While specific side effects are not listed for TheraSphere GBM, similar treatments may cause headaches, nausea, fatigue, bleeding or infection at the catheter site; however individual experiences may vary.

FRONTIER Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My scans show my tumor has grown and is 1 to 5 cm in size.

Select...

I received less than 66 Gy of radiation to my brain.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

It has been long enough since my last cancer treatment to start a new one.

Select...

I've been on a stable or reducing steroid dose, not more than 6 mg of dexamethasone daily, for the last week.

Select...

My brain lesion can be safely treated with TheraSphere GBM through microcatheter.

Select...

I have been diagnosed with glioblastoma according to the latest standards.

Select...

My brain treatment area is small and not in the part that controls vital functions.

Select...

I've had surgery and was treated with both radiation and chemotherapy, possibly including Tumor Treating Fields.

FRONTIER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment through 6 months post index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment through 6 months post index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through 6 months post index procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Operative Surgical Procedures

The number of Grade 4 neutropenia events persisting for longer than 5 days

The number of grade 3-5 non-hematological toxicities

+3 more

Secondary outcome measures

Change in post-treatment neurological function as assessed by the National Institute of Health Stroke Scale (NIHSS).

Change in post-treatment neurological function as assessed by the modified Rankin Scale (mRS).

Objective Response Rate* (ORR) from first patient enrolled through study completion

+4 more

FRONTIER Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor

720 Previous Clinical Trials

933,010 Total Patients Enrolled

2 Trials studying Glioblastoma

13 Patients Enrolled for Glioblastoma

Media Library

TheraSphere GBM (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05303467 — Phase < 1

Glioblastoma Research Study Groups: Treatment

Glioblastoma Clinical Trial 2023: TheraSphere GBM Highlights & Side Effects. Trial Name: NCT05303467 — Phase < 1

TheraSphere GBM (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05303467 — Phase < 1

Glioblastoma Patient Testimony for trial: Trial Name: NCT05303467 — Phase < 1

Frequently Asked Questions

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

What is the upper limit for individuals participating in this trial?

"This trial necessitates the participation of 12 eligible individuals. Those interested can join from Mayo Jacksonville in Florida or Northwestern Univerity in Illinois."

Answered by AI

Are participants currently being accepted for this clinical investigation?

"Yes, current data from clinicaltrials.gov confirms that this research project is looking to recruit 12 individuals at five locations. It was first uploaded on July 30th 2022 and was recently updated on November 8th 2022."

Answered by AI

How many health care centers are currently conducting this research project?

"This scientific study is currently recruiting from 5 different sites; Jacksonville, Chicago and San Francisco are among them. To reduce travel overhead when enrolling in the trial, it can be beneficial to select a centre close by."

Answered by AI

Who else is applying?

What site did they apply to?

Lenox Hill Hospital

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I had surgery twice. I had recurrence of the tumor. I underwent a second surgery. It is expected that the tumor will come back. In my country, The Netherlands there are no therapeutic options anymore. Even so we don't have trials in Europe.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM

2022. "A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05303467.

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