Radiation Therapy for Brain Cancer

(INSIGHT MRL Trial)

JY
CT
Overseen ByCancer Trials Inbox
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation therapy approach for individuals with high-grade glioma, an aggressive brain cancer. Researchers aim to determine if Hypofractionated Radiation Therapy, combined with the drug Temozolomide, is safe and tolerable for patients. Ideal participants have a diagnosis of Grade 3 or 4 glioma, have undergone surgery, and can receive MR-Linac radiation therapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypofractionated radiation therapy, which involves administering larger doses of radiation over a shorter period, is generally safe for treating brain cancer, such as high-grade glioma. One study with 127 patients found no major differences in survival rates with this method. Another study found that combining this therapy with Temozolomide, a chemotherapy drug, was both safe and effective.

Temozolomide is a common treatment for brain tumors and is usually well-tolerated. However, some patients might experience side effects like low blood cell counts, which are typically manageable. A study found that treatment breaks were not more common with the standard dose used in trials, suggesting that most patients can handle the treatment well.

In summary, research has shown that both hypofractionated radiation therapy and Temozolomide are safe and generally well-tolerated, although some side effects may occur.12345

Why do researchers think this study treatment might be promising for brain cancer?

Unlike the standard treatments for brain cancer, which often rely on conventional radiation therapy and chemotherapy, the study treatment combines Magnetic Resonance (MR)-Linac Radiation Therapy with Temozolomide. This innovative approach uses an MR-Linear Accelerator system for precise radiation delivery, potentially improving targeting accuracy and minimizing damage to healthy brain tissue. Researchers are excited about this treatment because it might enhance the effectiveness of radiation therapy while reducing side effects, offering a new level of precision in treating brain cancer.

What evidence suggests that this trial's treatments could be effective for high grade glioma?

Research has shown that hypofractionated radiation therapy, which uses shorter, higher doses, can effectively treat glioblastoma, a type of brain cancer. One study found that patients lived for a median of 12 months, achieving similar survival rates to traditional radiation but in a shorter treatment time. In this trial, participants will receive a combination of MR-Linac Radiation Therapy and temozolomide, a chemotherapy drug. Studies have demonstrated that combining radiation with temozolomide can lead to better outcomes. Specifically, one study found that using both radiation and temozolomide more than doubled the two-year survival rate compared to radiation alone. This combination treatment is now a standard approach to improve survival for brain cancer patients.16789

Who Is on the Research Team?

JY

Jonathan Yang, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults (18+) with newly diagnosed, high-grade glioma (grade 3 or 4, IDH wild-type) who have had surgery and can start radiation within 6 weeks. Participants must be able to undergo MRI-guided radiotherapy, have good organ function, and not be pregnant or breastfeeding.

Inclusion Criteria

I have had surgery using FastGlioma.
Ability to understand and the willingness to sign a written informed consent document
I had surgery less than 6 weeks ago.
See 7 more

Exclusion Criteria

Inability to tolerate immobilization in a head thermoplastic mask
My cancer has tested positive for an IDH mutation.
I do not have any lingering moderate or severe side effects from past cancer treatments.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MR-Linac Radiation Therapy with concurrent Temozolomide for 3 weeks

3 weeks
Daily visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Hypofractionated Radiation Therapy
  • Temozolomide

Trial Overview

The study tests the safety of using an MR-Linac machine to deliver higher doses of targeted radiation therapy after surgery for aggressive brain tumors. All patients also receive standard chemotherapy with temozolomide.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MRL-RT + TemozolomideExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Hypofractionated radiotherapy for glioblastoma: correlation ...

The purpose was to evaluate the efficacy of hypofractionated radiotherapy (HFRT) followed by conventional fractionated radiotherapy (CFRT) ...

Efficacy and Safety of Hypofractionated Radiotherapy for the ...

Background: Hypofractionated radiotherapy (HFR) is sometimes used in the treatment of glioblastoma multiforme (GBM). The efficacy and safety of HFR is still ...

Comparative Outcomes of Standard Radiation Therapy ...

A pivotal phase 3 study showed that 5-fraction hypofractionated RT is as effective as a 15-fraction course in elderly or frail patients, without added toxicity, ...

Are three weeks hypofractionated radiation therapy (HFRT) ...

Conclusion: HFRT with concomitant and adjuvant TMZ chemotherapy is an effective and safe treatment. INTRODUCTION. The standard of care for newly ...

Radiotherapy for elderly patients with glioblastoma

Hypofractionated radiation has emerged as a shortened alternative and retrospective studies have suggested survival outcomes are similar for ...

Efficacy and safety of hypofractionated radiotherapy ...

In this exploratory single-center retrospective study, individually tailored HFRT combined with concurrent TMZ demonstrated promising preliminary survival ...

Hypofractionated radiotherapy for glioblastoma - PMC - NIH

In this analysis of 127 patients with GBM receiving hypofractionated RT, we observed no differences in survival outcomes for individuals receiving 3w-RT and 4w- ...

Modified Target Delineation and Moderately ...

This randomized clinical trial of patients with high-grade glioma compares the efficacy and safety of multimodal magnetic resonance imaging ...

Radiation therapy for glioblastoma: Executive summary of ...

Nonrandomized data in this population suggest hypofractionated RT with TMZ is safe and efficacious (KQ2F). For example, a phase 2 multicenter trial combined 40 ...