60 Participants NeededMy employer runs this trial

Adaptive Radiotherapy for Glioblastoma

(UNITED-4 Trial)

HC
Overseen ByHanbo Chen, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sunnybrook Health Sciences Centre
Must be taking: Temozolomide
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 method of delivering radiation therapy for glioblastoma, a type of brain cancer. The study explores whether "dose painting" with smaller treatment areas can better control the cancer compared to standard radiation therapy. Researchers aim to assess how this approach impacts patients' survival, quality of life, and any side effects. The trial suits individuals diagnosed with glioblastoma or a similar brain tumor who qualify for combined chemotherapy and radiation treatment. Participants should be able to undergo MRI scans and have had a biopsy or surgery within the past 12 weeks. As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves concurrent chemoradiotherapy with temozolomide, it's best to discuss your current medications with the study team.

What prior data suggests that this adaptive radiotherapy approach is safe for glioblastoma patients?

Research has shown that adaptive radiation therapy (ART) for glioblastoma is generally safe and well-tolerated. Studies have linked ART to better survival rates and minimal side effects. One study found that precisely focusing the radiation on the tumor, known as dose-painting, can be done safely and consistently, even in challenging cases.

Overall, evidence suggests that this method does not increase the risk of cancer returning near the treated area. These findings support the safety of using adaptive radiation therapy with smaller treatment areas for glioblastoma.12345

Why are researchers excited about this trial?

Adaptive radiotherapy for glioblastoma is unique because it uses a technique called "dose painting" with reduced radiation margins. Unlike standard treatments, which typically deliver a uniform radiation dose to the tumor, dose painting allows for the customized delivery of higher radiation doses to specific parts of the tumor that are more aggressive. This targeted approach aims to maximize the destruction of cancer cells while minimizing damage to healthy tissue. Researchers are excited about this method because it could potentially improve treatment precision and effectiveness, offering new hope for patients with this challenging type of brain cancer.

What evidence suggests that this adaptive RT approach is effective for glioblastoma?

Research has shown that adaptive radiation therapy (ART) for glioblastoma can help patients live longer with fewer side effects. In this trial, participants will receive ART using a technique called dose painting, which targets higher radiation doses directly on the tumor with detailed imaging. Studies have found that ART does not increase the risk of cancer recurrence at the edges of the treated area. This method has been linked to better survival rates. Specifically, another study found that ART enhances the precision of radiation delivery while protecting healthy brain tissue. Overall, ART, including dose painting with smaller treatment areas, appears promising for effectively treating glioblastoma.13678

Are You a Good Fit for This Trial?

This trial is for adults with recently diagnosed glioblastoma or grade 4 astrocytoma who had a biopsy or surgery within the last 12 weeks, are expected to live at least 3 more months, have good kidney function, and can receive both radiation and chemotherapy. They must be able to attend treatments and follow-up visits.

Inclusion Criteria

I had a biopsy or surgery within the last 12 weeks.
* Expected survival ≥ 12 weeks
I have a confirmed diagnosis of glioblastoma or grade 4 astrocytoma.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive radiation therapy using MR-Linac with either 30 treatments over 6 weeks or 15 treatments over 3 weeks

3-6 weeks
Daily visits for radiation treatment

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

0-25 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dose painting + Reduced Margins

Trial Overview

The study compares a new type of adaptive radiation therapy called 'dose painting' with smaller treatment margins against standard radiation therapy in people with glioblastoma. The goal is to see if this approach improves tumor control and survival while reducing side effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Adaptive RT (Dose Painting)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Citations

Adaptive radiation therapy for glioblastoma: clinical efficacy ...

Conclusions. ART for GBM is associated with favorable survival outcomes and low toxicity. ART does not increase the risk of marginal recurrence, ...

A Pipeline for MRI-Guided dose painting by number ...

The idea of dose painting radiotherapy treatments is to escalate the dose to tumor volumes based on functional image data characteristics. In contrast with ...

Dose-painting multicenter phase III trial in newly diagnosed ...

These interesting dose-increase studies in newly diagnosed glioblastomas showing positive effects on survival did included neither concomitant ...

Radiotherapy in Glioblastoma Multiforme: Evolution, ...

An institutional study reported an mOS of 19.8 months [77], and a meta-analysis showed a 12-month OS of 71.3% across various ages [78]. Hyperfractionation shows ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35193635/

A prospective comparison of adaptive and fixed boost ...

Conclusion: ART for glioblastoma improved the target coverage and dose reduction for the normal brain. By analyzing the results according to ...

Repeatability of radiotherapy dose-painting prescriptions ...

With this approach, we found that dose-painting plans can be feasibly generated with high repeatability, even in cases of GBM patients where the tumour is in a ...

guided dose painting radiotherapy in glioblastoma

In this study, we evaluate the practical application of a multiparametric MRI model of glioma infiltration for DP radiotherapy in GBM by measuring its ...

Dose-Painting Proton Radiotherapy Guided by Functional ...

The maximum safe dose for IMRT was 84 Gy and 96 GyE for PRT, according to TCP and NTCP for the Brain-PTV volume i.e. for OARs beyond the PTV.