Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT05393258
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intensity modulated RT (IMRT) using single or two arc therapy will be used for RT delivery.
Other names: pulsed low-dose-rate RT (PLRT), pulsed reduced-dose-rate RT (PRRT)
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.
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
Time frame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
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.
Time frame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
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.
Time frame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
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).
Time frame: At one year after start of treatment
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).
Time frame: At one year after start of treatment
OS is defined as the time from start of treatment until the date of death due to any cause.
Time frame: From start of treatment through month 12 follow-up
Time frame: At baseline and week 6 of radiation therapy.
Blood will be collected before the start of TMPRT and at week 6 of radiation therapy to assess for changes in myeloid cells.
Time frame: At baseline and week 6 of radiation therapy.
Blood will be collected before the start of TMPRT and at week 6 of radiation therapy to assess for changes in circulating T-cells.
Washington University School of Medicine
Other
A Pilot Study of Temporally-modulated Pulsed Radiation Therapy to Reirradiate Recurrent IDH-mutant Gliomas After Prior External Beam Radiation Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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