GlioblastomaPhase 2NCT04747145
Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma
A Phase 2 study testing Radiation, Concurrent Chemotherapy (Temozolomide) and Adjuvant Chemotherapy (Temozolomide) in people with Glioblastoma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The primary protocol objective is to assess the impact of substituting pulsed reduced dose radiotherapy (pRDR) for standard radiation therapy in the upfront treatment of glioblastoma (GBM) on disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Radiation, Concurrent Chemotherapy (Temozolomide) and Adjuvant Chemotherapy (Temozolomide)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to Sep 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
- Voluntary written consent must be given before performance of any study-related procedure that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female or male subjects ≥ 18 years old at the time of informed consent.
- Histologically confirmed new diagnosis of GBM according to updated World Health Organization (WHO) classification criteria.
- Supratentorial tumor location.
- Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable).
- Planned for standard adjuvant chemoradiotherapy of approximately 60 Gy of radiation therapy (RT) , or biologically equivalent dose, according to local practice, and concomitant TMZ chemotherapy (75 mg/m^2 daily) Any other cytotoxic or biologic antitumor therapy received prior to enrollment will be considered an exclusion.
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- Planned treatment with adjuvant/maintenance TMZ (150 to 200 mg/m^2 daily x 5 d, q 28 days).
- All patients with sufficient tissue must have had tissue submitted for O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation determination prior to enrollment.
- Karnofsky Performance Status Scale ≥ 70.
- Life expectancy greater than at least three months.
- Study start date at least three weeks out from brain surgery.
- Stable or decreasing dose of corticosteroids for the last seven days prior to enrollment, if applicable.
- Complete blood count (CBC) /differential obtained within 28 days prior to registration, with adequate bone marrow function defined as follows: absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3; platelets ≥ 100,000 cells/mm^3; hemoglobin ≥ 10.0 g/dL. (Note: the use of transfusion or other intervention to achieve Hgb ≥10.0 g/dL is acceptable.)
- Female subjects who:
- Are postmenopausal for at least one year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential:
- Agree to practice one highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through four months after the last study intervention (female and male condoms should not be used together), OR ii. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
- Male subjects, even if surgically sterilized (i.e., status postvasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through four months after the last study intervention (female and male condoms should not be used together), OR
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
Who cannot join
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years. (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Recurrent or multifocal malignant gliomas.
- Any site of distant disease (i.e., leptomeningeal disease or drop metastases from the GBM tumor site).
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
- Severe, active comorbidity, defined as follows:
- Unstable angina at registration.
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- Transmural myocardial infarction within the last six months prior to registration.
- Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of ≥ 2 mm using the analysis of an EKG performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue.)
- New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to.
- Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
- New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration.
- Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
- End-stage renal disease (i.e., on dialysis or dialysis has been recommended).
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Patents treated on any other therapeutic clinical protocols within 30 days prior to registration.
- Inability to undergo MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Phase II Study Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma (PRORADGLIO Study)
The primary protocol objective is to assess the impact of substituting pulsed reduced dose radiotherapy (pRDR) for standard radiation therapy in the upfront treatment of glioblastoma (GBM) on disease progression.
Read the detailed description
This is a single-arm, single-center phase 2 study designed to assess the efficacy of pulsed reduced dose-rate radiotherapy in the initial treatment of maximally safely resected glioblastoma. The primary endpoint will be progression-free survival at six months. Patients with pathologically confirmed GBM who are planned for six weeks of adjuvant chemoradiation followed by six to12 months of adjuvant chemotherapy will be screened and enrolled after surgery.
- Conditions
- Glioblastoma
- Being tested
- Radiation, Concurrent Chemotherapy (Temozolomide), Adjuvant Chemotherapy (Temozolomide)
- Keywords
- pulsed reduced dose radiotherapy, glioblastoma, pRDR
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationDevice
Also called Pulsed Reduced Dose Radiotherapy, pRDR
60 Gy to be delivered over 30 daily treatments in six weeks. Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
Concurrent Chemotherapy (Temozolomide)Drug
Also called TMZ, Temodar
75mg/m^2 x 42 days (concurrent chemotherapy with radiation). Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
Adjuvant Chemotherapy (Temozolomide)Drug
Also called TMZ, Temodar
Starting no sooner than 4 weeks after completion of chemoradiation, 150-200mg/m^2, days 1-5 of 28-day cycle, for minimum of six cycles and up to 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed reduced dose-rate radiotherapy | Experimental | Chemoradiation, adjuvant chemotherapy. Receives: Device: Radiation; Drug: Concurrent Chemotherapy (Temozolomide); Drug: Adjuvant Chemotherapy (Temozolomide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
This outcome measure is the number of subjects whose disease has not progressed using the Macdonald Response Criteria, which has the following classifications: complete response, partial response, stable disease and progression.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start3 Jun 2021
- Primary completion5 Mar 2025
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Straza, MD, PhD, Medical College of Wisconsin
- Investigators
- Michael Straza, MD, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747145
- Sponsor's protocol ID
- PRO00039277
- Status last verified
- Aug 2025
- First submitted
- 6 Feb 2021
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma (PRORADGLIO Study)
- ClinicalTrials.gov ID
- NCT04747145
- Acronym / sponsor ID
- PRO00039277
- Conditions
- Glioblastoma
- Keywords
- pulsed reduced dose radiotherapy, glioblastoma, pRDR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary protocol objective is to assess the impact of substituting pulsed reduced dose radiotherapy (pRDR) for standard radiation therapy in the upfront treatment of glioblastoma (GBM) on disease progression.
Detailed description
This is a single-arm, single-center phase 2 study designed to assess the efficacy of pulsed reduced dose-rate radiotherapy in the initial treatment of maximally safely resected glioblastoma. The primary endpoint will be progression-free survival at six months. Patients with pathologically confirmed GBM who are planned for six weeks of adjuvant chemoradiation followed by six to12 months of adjuvant chemotherapy will be screened and enrolled after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed reduced dose-rate radiotherapy | Experimental | Device: Radiation, Drug: Concurrent Chemotherapy (Temozolomide), Drug: Adjuvant Chemotherapy (Temozolomide)Chemoradiation, adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Voluntary written consent must be given before performance of any study-related procedure that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female or male subjects ≥ 18 years old at the time of informed consent.
- Histologically confirmed new diagnosis of GBM according to updated World Health Organization (WHO) classification criteria.
- Supratentorial tumor location.
- Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable).
Key exclusion criteria (16 listed)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years. (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Recurrent or multifocal malignant gliomas.
- Any site of distant disease (i.e., leptomeningeal disease or drop metastases from the GBM tumor site).
- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
- Severe, active comorbidity, defined as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationAlso: Pulsed Reduced Dose Radiotherapy, pRDR60 Gy to be delivered over 30 daily treatments in six weeks. Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks. | Device | Pulsed reduced dose-rate radiotherapy |
| Concurrent Chemotherapy (Temozolomide)Also: TMZ, Temodar75mg/m^2 x 42 days (concurrent chemotherapy with radiation). Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks. | Drug | Pulsed reduced dose-rate radiotherapy |
| Adjuvant Chemotherapy (Temozolomide)Also: TMZ, TemodarStarting no sooner than 4 weeks after completion of chemoradiation, 150-200mg/m^2, days 1-5 of 28-day cycle, for minimum of six cycles and up to 12 cycles. | Drug | Pulsed reduced dose-rate radiotherapy |
Primary outcome
Progression-free survival
Time frame: Six months
This outcome measure is the number of subjects whose disease has not progressed using the Macdonald Response Criteria, which has the following classifications: complete response, partial response, stable disease and progression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Straza, MD, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation, Concurrent Chemotherapy (Temozolomide) and Adjuvant Chemotherapy (Temozolomide) in people with Glioblastoma, run by Medical College of Wisconsin 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 21 inclusion and 16 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 21 Aug 2025. 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?
Progression-free survival (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2025.