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Radiation Therapy

Preoperative Radiosurgery for Brain Tumor

Phase 1

Recruiting

Led By Daniel M. Trifiletti, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

No prior history of cranial radiotherapy

Planning to receive adjuvant radiotherapy at enrolling institution

Must not have

Unwillingness to participate in study

Nursing women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether radiosurgery before surgery can improve brain tumor control and reduce side effects.

Who is the study for?

Adults with high grade glioma (brain tumor) who are planning surgery and radiotherapy, have good blood counts, no prior cranial radiotherapy, can perform daily activities with minimal help (ECOG PS ≤2), not pregnant or nursing, agree to use contraception if of childbearing potential, and can provide consent. Excludes those with non-MRI compatible devices, recent cancer therapy within 3 months, medical issues preventing surgery or known low-grade gliomas.

What is being tested?

The NeoGlioma Study is testing the effectiveness of radiosurgery before conventional brain tumor surgery. The goal is to see if this approach improves tumor control while reducing side effects compared to traditional methods that involve multiple radiation doses over a longer period.

What are the potential side effects?

Potential side effects include damage to surrounding brain tissue leading to neurological deficits, fatigue from radiation exposure, skin irritation at the treatment site and general discomfort associated with any form of radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

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I have never had radiation therapy to my head.

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I plan to get additional radiation therapy at the institution where I am enrolling.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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I am scheduled for surgery to remove a brain tumor.

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My brain tumor is a high-grade glioma as confirmed by experts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing to participate in the study.

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I am currently breastfeeding.

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I cannot undergo surgery to remove a brain tumor due to health risks.

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I haven't had any cancer treatment in the last 3 months.

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My cancer originates in my spinal cord or brainstem.

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I am of childbearing age and do not plan to use birth control.

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I am willing and able to follow the study's procedures.

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My brain tumor is confirmed to be low or intermediate grade.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute clinical toxicity

Maximum tolerated dose (MTD) of preoperative radiosurgery

Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event

Secondary study objectives

Overall survival

Radiographic tumor control

Rate of pseudoprogression

Other study objectives

Tumor tissue evaluation of tumor changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (stereotactic biopsy, radiosurgery, surgery)Experimental Treatment9 Interventions

Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tumor Treating Fields Therapy

2018

Completed Early Phase 1

~30

Radiation Therapy

2017

Completed Phase 3

~7250