AstrocytomaNCT05393258
Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas
A study testing temporally-modulated pulsed radiotherapy (TMPRT) in people with Astrocytoma and Oligodendroglioma, Adult, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Oligodendroglioma, Adult, Glioma, Malignant
- What is being tested?
- temporally-modulated pulsed radiotherapy (TMPRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histologically confirmed recurrent IDH-mutant gliomas (either astrocytoma or oligodendroglioma) with prior external beam radiation therapy (EBRT) to the same region. The recurrent tumor may be either histologically confirmed or based on clinical assessment. Any number of prior recurrences is allowed.
- Maxium tumor diameter of 7 cm or less.
- Prior EBRT is ≥ 2 years ago.
- The region for reirradiation should have received at least 45 Gy from the prior EBRT but no more than 75 Gy. The prior EBRT could be either photon-based or proton-based.
- Prior SRS to the same region is permitted as long as the cumulative dose of EBRT plus SRS is no more than 75 Gy. The prior SRS should be completed at least 6 months ago.
- Life expectancy ≥ 12 months
Show all 10Show fewer
- At least 18 years of age.
- Karnofsky performance status (KPS) of at least 70%.
- Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).
Who cannot join
- Leptomeningeal or metastatic involvement.
- Prior history of grade 3 or higher radiation necrosis that is at least possibly related to prior radiotherapy.
- Use of concurrent bevacizumab or other anti-VEGF-directed therapy during TMPRT is not allowed. If the patient is on bevacizumab, the patient needs to discontinue bevacizumab for at least 4 weeks prior to the start of TMPRT and remain stable. Other chemotherapy, immunotherapy, or target therapy can be used concurrently or adjuvantly at the discretion of treating physician.
- Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
- Pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Pilot Study of Temporally-modulated Pulsed Radiation Therapy to Reirradiate Recurrent IDH-mutant Gliomas After Prior External Beam Radiation Therapy
This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. This technique may improve efficacy while reducing toxicity and improving patient quality of life.
- Conditions
- Astrocytoma, Oligodendroglioma, Adult, Glioma, Malignant
- Being tested
- temporally-modulated pulsed radiotherapy (TMPRT)
- Keywords
- IDH mutant glioma, astrocytoma, oligodendroglioma
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporally-modulated pulsed radiotherapy (TMPRT)Radiation
Also called pulsed low-dose-rate RT (PLRT), pulsed reduced-dose-rate RT (PRRT)
Intensity modulated RT (IMRT) using single or two arc therapy will be used for RT delivery.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: temporally-modulated pulsed radiotherapy (TMPRT) | Experimental | Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity. Receives: Radiation: temporally-modulated pulsed radiotherapy (TMPRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute intolerable toxicities
Intolerable toxicities are defined as grade 3 or higher central nervous system (CNS) adverse events at least possibly related to radiation as graded by the Common Terminology Criteria for Adverse Events v5.0 with the exception of grade 3 fatigue, headache, nausea, and vomiting. Any serious adverse event leading to discontinuation of TMPRT that is at least possibly related will be considered an intolerable toxicity.
Measured: From start of treatment through 3 months
Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events
Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Measured: From start of treatment through 1 year
Secondary outcomes (6)
Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
The MDASI-BT consists of 23 symptom questions asking the patient to rate the severity of their symptoms in the last 24 hours. The range is an 11-point scale (0 to 10), with 0 being "not present" and 10 being "as bad as you can imagine". The symptom composite score is the average of the symptoms items, and the score ranges from 0 to 23 with a higher score indicating more severe symptoms. Symptom burden deterioration is defined as an increase of more than 1 point from baseline on the composite symptom scale.
Measured: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
Change in interference as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
The MDASI-BT consists of 6 interference questions asking the participant to rate how their symptoms interfered with how they felt and functioned in the last 24 hours. The range is an 11-point scale (0 to 10), with 0 being "did not interfere" and 10 being "interfered completely". The interference composite score is the average of the 6 items on interferences, with a higher score indicating more interference. Interference deterioration is defined as an increase of more than 1 point from the baseline on the interference score.
Measured: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
Change in quality of life (QOL) as measured by self-reported QOL on the Linear Analog Scale Assessment (LASA)
The LASA is a single-item questionnaire that asks the participants to rate their overall quality of life. The LASA scale runs from 0 (as bad as it can be) to 10 (as good as it can be).
Measured: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
Progression-free survival (PFS)
PFS is defined as the time from start of treatment until time of disease progression or death from any cause. Progression will be evaluated per standard clinical care based on the Response Assessment in Neuro-Oncology (RANO) criteria for low-grade glioma (van dent Bent et al., 2011).
Measured: At one year after start of treatment
Overall survival (OS)
OS is defined as the time from start of treatment until the date of death due to any cause.
Measured: At one year after start of treatment
Number of reirradiation adverse events
Measured: From start of treatment through month 12 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start28 Jun 2022
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiayi Huang, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393258
- Sponsor's protocol ID
- 202205105
- Status last verified
- Mar 2026
- First submitted
- 23 May 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Temporally-modulated Pulsed Radiation Therapy to Reirradiate Recurrent IDH-mutant Gliomas After Prior External Beam Radiation Therapy
- ClinicalTrials.gov ID
- NCT05393258
- Acronym / sponsor ID
- 202205105
- Conditions
- Astrocytoma, Oligodendroglioma, Adult, Glioma, Malignant
- Keywords
- IDH mutant glioma, astrocytoma, oligodendroglioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 26 May 2022 (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.
This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. This technique may improve efficacy while reducing toxicity and improving patient quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: temporally-modulated pulsed radiotherapy (TMPRT) | Experimental | Radiation: temporally-modulated pulsed radiotherapy (TMPRT)Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed recurrent IDH-mutant gliomas (either astrocytoma or oligodendroglioma) with prior external beam radiation therapy (EBRT) to the same region. The recurrent tumor may be either histologically confirmed or based on clinical assessment. Any number of prior recurrences is allowed.
- Maxium tumor diameter of 7 cm or less.
- Prior EBRT is ≥ 2 years ago.
- The region for reirradiation should have received at least 45 Gy from the prior EBRT but no more than 75 Gy. The prior EBRT could be either photon-based or proton-based.
- Prior SRS to the same region is permitted as long as the cumulative dose of EBRT plus SRS is no more than 75 Gy. The prior SRS should be completed at least 6 months ago.
Key exclusion criteria (5 listed)
- Leptomeningeal or metastatic involvement.
- Prior history of grade 3 or higher radiation necrosis that is at least possibly related to prior radiotherapy.
- Use of concurrent bevacizumab or other anti-VEGF-directed therapy during TMPRT is not allowed. If the patient is on bevacizumab, the patient needs to discontinue bevacizumab for at least 4 weeks prior to the start of TMPRT and remain stable. Other chemotherapy, immunotherapy, or target therapy can be used concurrently or adjuvantly at the discretion of treating physician.
- Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
- Pregnant.
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 |
|---|---|---|
| temporally-modulated pulsed radiotherapy (TMPRT)Also: pulsed low-dose-rate RT (PLRT), pulsed reduced-dose-rate RT (PRRT)Intensity modulated RT (IMRT) using single or two arc therapy will be used for RT delivery. | Radiation | Arm 1: temporally-modulated pulsed radiotherapy (TMPRT) |
Primary outcome
Frequency of acute intolerable toxicities
Time frame: From start of treatment through 3 months
Intolerable toxicities are defined as grade 3 or higher central nervous system (CNS) adverse events at least possibly related to radiation as graded by the Common Terminology Criteria for Adverse Events v5.0 with the exception of grade 3 fatigue, headache, nausea, and vomiting. Any serious adverse event leading to discontinuation of TMPRT that is at least possibly related will be considered an intolerable toxicity.
Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events
Time frame: From start of treatment through 1 year
Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
6 secondary outcomes
Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Time frame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
Change in interference as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Time frame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
Change in quality of life (QOL) as measured by self-reported QOL on the Linear Analog Scale Assessment (LASA)
Time frame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
Progression-free survival (PFS)
Time frame: At one year after start of treatment
Overall survival (OS)
Time frame: At one year after start of treatment
Number of reirradiation adverse events
Time frame: From start of treatment through month 12 follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Jiayi Huang, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing temporally-modulated pulsed radiotherapy (TMPRT) in people with Astrocytoma and Oligodendroglioma, Adult, run by Washington University School of Medicine 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 17 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of acute intolerable toxicities (time frame: From start of treatment through 3 months). The study lists 2 primary outcomes in all. 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 17 Mar 2026.