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MR-Guided Adaptive Radiotherapy + Temozolomide for Glioblastoma

Phase 2

Recruiting

Led By Michelle Kim, MD

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

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

Must have

Adequate bone marrow reserve (Hemoglobin ≥ 10 g/dL, absolute neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3), acceptable liver function (total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), and ALT/AST ≤ 5 x ULN) and renal function (serum creatinine ≤ 2.0 mg/dL) within 14 day prior to registration. Eligibility level for hemoglobin may be reached by transfusion.

Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment and study participation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test if a new radiation therapy method can help people with glioblastoma live longer.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma who can give informed consent, follow study procedures, and have a life expectancy of at least 12 weeks. They should be in good physical condition (Karnofsky score ≥70), have adequate organ function, and agree to use contraception if applicable. The tumor must be ≤5 cm in diameter and patients must enroll within 6 weeks post-surgery.Check my eligibility

What is being tested?

The study tests if intensified radiation therapy targeted at high-risk tumor areas during treatment improves survival in glioblastoma patients compared to standard chemoradiotherapy. It includes dose-intensified radiotherapy with concurrent temozolomide followed by adjuvant temozolomide.See study design

What are the potential side effects?

Potential side effects include fatigue, skin irritation at the radiation site, nausea, low blood counts leading to increased infection risk or bleeding problems, liver and kidney function changes, headaches, hair loss around the treated area.

Eligibility Criteria

Inclusion Criteria

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

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My blood, liver, and kidney functions meet the required levels for the trial.

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I am not pregnant and agree to use birth control during the study.

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My tumor is 5 cm or smaller on a specific MRI scan.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

12-month overall survival rate

Secondary outcome measures

Advanced MRI Gross tumor volume (GTV) and its association with overall survival

Grade 3 or higher treatment-related toxicities

Overall survival

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with Newly Diagnosed GlioblastomaExperimental Treatment3 Interventions

Patients will receive dose-intensified, adaptive photon radiation therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1930

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

24,231 Total Patients Enrolled

4 Trials studying Glioblastoma

133 Patients Enrolled for Glioblastoma

Michelle Kim, MDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

29 Total Patients Enrolled

Media Library

Dose-Intensified Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04574856 — Phase 2

Glioblastoma Research Study Groups: Patients with Newly Diagnosed Glioblastoma

Glioblastoma Clinical Trial 2023: Dose-Intensified Radiotherapy Highlights & Side Effects. Trial Name: NCT04574856 — Phase 2

Dose-Intensified Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574856 — Phase 2

Frequently Asked Questions

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

How many participants are involved in this clinical trial at its peak enrollment?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical research is actively seeking out participants and was originally published in November 2020 before being last updated in December 2021. This trial needs 30 volunteers from one centre."

Answered by AI

How hazardous is Dose-Intensified Radiotherapy for those exposed to it?

"The safety of Dose-Intensified Radiotherapy was ranked a 2 on our scale, as this Phase 2 trial has only provided initial evidence that it is safe with no data concerning its efficacy."

Answered by AI

Is this investigative research the inaugural of its kind?

"Since its initial study in 2002, sponsored by Schering-Plough, the use of Dose-Intensified Radiotherapy has grown significantly - today there are 206 active trials occurring across 935 cities and 36 nations. After its first evaluation involving 60 patients, this treatment was officially approved for Phase 2 drug testing."

Answered by AI

What has been the traditional application of Dose-Intensified Radiotherapy?

"Dose-Intensified Radiotherapy is an effective therapy for nitrosourea treatment, advanced mycosis fungoides, refractory neuroblastoma and other conditions which do not respond to more conventional treatments."

Answered by AI

Is this research venture currently open to participants?

"Indeed, the data found on clinicaltrials.gov alludes to this medical trial actively recruiting participants. The study was first made public on November 4th 2020 and has been recently revised as of December 16th 2021. 30 intrepid volunteers are being sought at a single clinic for enrolment in the experiment."

Answered by AI

Are there any other experiments that have delved into the potential of dose-intensified radiotherapy?

"Presently, 206 clinical studies are in progress investigating Dose-Intensified Radiotherapy. Of these ongoing trials, 23 have reached Phase 3 status. Although the majority of research is taking place Songpa, Seoul, a total of 4751 medical centres worldwide are running investigations into this form of therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma

2020. "Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04574856.

All > Recurrent Glioblastoma > Glioblastoma Multiforme