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Radiation

Adaptive Radiotherapy for Glioblastoma (UNITED2 Trial)

Phase 2

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 months

Awards & highlights

UNITED2 Trial Summary

This trial is testing if giving higher radiation doses than usual over a shorter time period combined with technology to adapt to tumour dynamics can improve survival rates in elderly GBM/Grade 4 astrocytoma patients.

Who is the study for?

This trial is for people over 65 with a recent diagnosis of glioblastoma or Grade 4 astrocytoma, IDH-mutant. They must have had surgery or biopsy within the last 6 weeks and be fit enough for daily radiation treatments over three weeks alongside chemotherapy. Participants need to expect to live at least another 12 weeks, be able to do some quality of life questionnaires in English, and have kidneys working well enough for MRI contrast.Check my eligibility

What is being tested?

The study tests if giving a higher dose of radiation (like what younger patients get) over three weeks using MR-Linac technology can help older patients with high-grade brain tumors better than standard treatment. The MR-Linac allows doctors to adjust the plan daily based on MRI scans before each treatment session.See study design

What are the potential side effects?

Potential side effects may include skin reactions from radiotherapy, fatigue, nausea from chemotherapy, headaches or swelling due to increased pressure in the brain area being treated. There might also be risks associated with frequent MRI scans such as discomfort or allergic reactions to contrast agents.

UNITED2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 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

Chemoradiotherapy

Secondary outcome measures

Compare differences in adaptive vs non-adaptive with regards to cumulative dose

Compare differences in adaptive vs non-adaptive with regards to length of radiation treatment time

Compare differences in adaptive vs non-adaptive with regards to organ-at-risk doses

+8 more

UNITED2 Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Concurrent dose-escalated chemoradiation with temozolomide (TMZ) on the MR-Linac with weekly adaptation

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,253 Total Patients Enrolled

3 Trials studying Glioblastoma

158 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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

Is enrollment for this experiment still open?

"Affirmative. According to clinicaltrials.gov, this trial is actively seeking patients after being initially posted on December 13th 2022 and most recently edited on November 6th 2023. 55 participants are expected at one medical centre for the study's duration."

Answered by AI

What potential risks do patients face when undergoing Treatment Arm?

"The safety of the new treatment arm is estimated to be a 2, as Phase 2 trials provide some evidence of its safety but lack supporting data for efficacy."

Answered by AI

How many participants have been approved to take part in this research?

"Indeed, according to the clinicaltrials.gov website, this investigation is in need of volunteers. The trial was published on December 13th 2022 and modified for the last time on November 6th 2023. A total of 55 participants are being enrolled at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly

Chia-Lin (Eric) Tseng 2022. "UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05565521.