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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temporally-modulated pulsed radiotherapy (TMPRT) | Radiation | Intensity modulated RT (IMRT) using single or two arc therapy will be used for RT delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative changes of different subtypes of myeloid cells | Blood will be collected before the start of TMPRT and at week 6 of radiation therapy to assess for changes in myeloid cells. | At baseline and week 6 of radiation therapy. |
| Relative changes of different subtypes of circulating T-cells |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiayi Huang, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| 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. | 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). | 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). | 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. | At one year after start of treatment |
| Number of reirradiation adverse events | From start of treatment through month 12 follow-up |
Blood will be collected before the start of TMPRT and at week 6 of radiation therapy to assess for changes in circulating T-cells. |
| At baseline and week 6 of radiation therapy. |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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