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AzTrials

GlioblastomaPhase 2NCT04574856

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

A Phase 2 study testing Dose-Intensified Radiotherapy, Temozolomide and Adjuvant temozolomide in people with Glioblastoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will investigate whether or not intensified radiation therapy adapted during the radiation treatment course to high-risk, treatment-resistant tumor regions will improve overall survival in patients with newly diagnosed glioblastoma (GBM) compared to conventional chemoradiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Dose-Intensified Radiotherapy, Temozolomide and Adjuvant temozolomide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
4 Nov 2020to 19 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
  • Karnofsky performance status >=70
  • Minimal life expectancy of 12 weeks
  • 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.
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  • Maximal contiguous diameter of tumor based on high b-value diffusion MRI and DCE perfusion MRI ≤5 cm
  • Patients must be registered within 6 weeks of most recent resection
  • 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.

Who cannot join

  • Recurrent glioma, or tumor involving the brainstem or cerebellum
  • Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is >3 years.
  • Evidence of CSF dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination)
  • Evidence of severe concurrent disease requiring treatment
  • Prior invasive malignancy (except non-melanoma skin cancer or non-life limiting invasive malignancy that may not require treatment, such as low-risk prostate cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible)
  • Patients unable to undergo MRI exams (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses [e.g. pins in artificial joints and surgical pins/clips], or unable to receive gadolinium for MRI, as per the standard Department of Radiology MRI screening criteria)
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  • Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap as determined by treating physician
  • Multifocal disease (>1 lobe of involvement) of discontiguous contrast enhancing disease as seen on conventional MRI
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: A Phase II Study of Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma

This study will investigate whether or not intensified radiation therapy adapted during the radiation treatment course to high-risk, treatment-resistant tumor regions will improve overall survival in patients with newly diagnosed glioblastoma (GBM) compared to conventional chemoradiotherapy.

Conditions
Glioblastoma
Being tested
Dose-Intensified Radiotherapy, Temozolomide, Adjuvant temozolomide
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dose-Intensified RadiotherapyRadiation

    Adaptive, dose-intensified radiotherapy targeting an advanced imaging signature, with a target, nominal radiotherapy dose of 80 Gy.

  • TemozolomideDrug

    Temozolomide chemotherapy (75 mg/m2 daily for 6 weeks)

  • Adjuvant temozolomideDrug

    Adjuvant temozolomide will be delivered at 150-200 mg/m2 days 1-5 every 28 days for 6 cycles, with additional cycles delivered at the discretion of the investigator.

Study groups in NCT04574856
Study groupRoleWhat they receive
Patients with Newly Diagnosed GlioblastomaExperimentalPatients will receive dose-intensified, adaptive photon radiation therapy
Receives: Radiation: Dose-Intensified Radiotherapy; Drug: Temozolomide; Drug: Adjuvant temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-month overall survival rate

    12-month overall survival rate of study participants (failure defined as death due to any cause)

    Measured: 12 months post radiation therapy (RT)

Secondary outcomes (8)

  1. Overall survival

    Overall survival (failure defined as death due to any cause)

    Measured: 2 years

  2. Progression-free survival rate

    Progression-free survival (failure defined as progression or death due to any cause) will be evaluated using standard response assessment in neuro-oncology (RANO) criteria.

    Measured: 2 years

  3. Proportion of failures classified by relation to the high-dose radiation region

    Patterns of failure (tumor growth) will be classified as follows:

    • Central: >95% of the tumor volume is within the high-dose radiation region
    • In-field: >80% to 95% of the tumor volume is within the high-dose radiation region
    • Marginal: 20-80% of the tumor volume is within the high-dose radiation region
    • Distant: <20% of the tumor volume is within the high-dose radiation region

    Measured: 2 years

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

    GTV is defined as the combined hypercellularity tumor volume and hyperperfused tumor volume, assessed by high b-value diffusion MRI and dynamic contrast-enhanced perfusion MRI, respectively. Patients will be grouped into those with less than 2.5 cc GTV and those with 2.5 cc or more GTV. This measure will be used to determine whether advanced MRI metrics can be used to distinguish pseudoprogression from true tumor progression, and to determine whether advanced MR-identified tumor volume 3 months post-chemoradiation is associated with survival.

    Measured: 3 months post-RT

  5. Patient-reported quality of life (QOL) using EORTC QLQ-C30 and BN20

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) is a validated questionnaire developed to assess the quality of life of cancer patients, with the EORTC QLQ-BN20 specifically for brain tumor patients. Patients will be classified as having deterioration if there is a clinically meaningful change (10 point drop from baseline) in the QOL scales. The percentage of patients with deterioration in each survey will be reported.

    Measured: Up to 12 months post-RT

  6. Patient-reported symptom burden using MDASI-BT

    The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) is a validated questionnaire developed to assess the symptom burden of brain tumor patients. Severity of symptoms is scored on a scale of 0-10, with 0 being "not present" and 10 being "as bad as you can imagine." Patients will be classified as having deterioration if there is a clinically meaningful change (1 point increase in symptom severity from baseline). The percentage of patients with deterioration will be reported.

    Measured: Up to 12 months post-RT

  7. Patient objective neurocognitive function

    Objective neurocognitive function (NCF) testing using Hopkins Verbal Learning Tests, Controlled Oral Word Association, and Trail Making Tests A and B. Test results will be reported as a composite, using the reliable change index (RCI) to categorize patients as improved, stable, or declined from baseline.

    Measured: Up to 12 months post-RT

  8. Grade 3 or higher treatment-related toxicities

    Rate of grade 3 or higher toxicities (neurologic and non-neurologic) of dose-intensified, adaptive chemoradiotherapy. Toxicity assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

    Measured: 12 months post-RT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start4 Nov 2020
  3. Primary completion19 Nov 2026 (estimated)
  4. Study completion19 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04574856
Sponsor's protocol ID
UMCC 2020.033
Other IDs
HUM00179427
Status last verified
Mar 2026
First submitted
28 Sep 2020
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kim MM, Aryal MP, Suresh K, Rosen BS, Parmar H, You D, Leung D, Clarke N, Fortunato J, Al-Holou W, Heth J, Altshuler D, Hollon T, Edwards DM, Wahl DR, Lawrence TS, Cao Y. A Phase 2 Study of Multiparametric Magnetic Resonance Imaging-Guided High-Dose Response-Adaptive Radiation Therapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma: Results From an Interim Analysis. Int J Radiat Oncol Biol Phys. 2025 Jul 1;122(3):605-610. doi: 10.1016/j.ijrobp.2025.02.020. Epub 2025 Mar 8.

    PubMed 40058709

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dose-Intensified Radiotherapy, Temozolomide and Adjuvant temozolomide in people with Glioblastoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month overall survival rate (time frame: 12 months post radiation therapy (RT)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04574856, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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