Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas

NCT05393258 | Completed DMC FDA Device

• 1 other identifier: 202205105
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

IDH mutant glioma; astrocytoma; oligodendroglioma

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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)

  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)

  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)

  Assessed at approximately 3 months, 6 months, and 12 months after start of treatment

• Progression-free survival (PFS)

  At one year after start of treatment

• Overall survival (OS)

  At one year after start of treatment

Other Outcomes (2)

• Relative changes of different subtypes of myeloid cells

  At baseline and week 6 of radiation therapy.

• Relative changes of different subtypes of circulating T-cells

  At baseline and week 6 of radiation therapy.

Study Arms (1)

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.

Radiation: temporally-modulated pulsed radiotherapy (TMPRT)

Interventions

temporally-modulated pulsed radiotherapy (TMPRT) RADIATION

Intensity modulated RT (IMRT) using single or two arc therapy will be used for RT delivery.

Also known as: pulsed low-dose-rate RT (PLRT), pulsed reduced-dose-rate RT (PRRT)

Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma; Glioma

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Jiayi Huang, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: June 28, 2022
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)