LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 22
SponsorM.D. Anderson Cancer Center
About this trial
This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
Patient may not receive chemotherapy concurrent with radiation
Signed informed consent by patient and/or parents or legal guardian
Disqualifiers
Patients with previous radiation therapy to the brain
Ependymoma of the spine
Disseminated ependymoma requiring craniospinal radiation therapy
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
RadiationGiven LET optimized IMPT
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Treatment (LET optimized IMPT)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events
The safety of linear energy transfer-optimized intensity modulated proton therapy will be defined by treatment failures which include imaging changes consistent with necrosis in the presence of Common Terminology Criteria for Adverse Events version 4.03 symptoms of grade 3 brain necrosis and/or local recurrence within the first 6 months from the end of proton therapy.
Time frame
Up to 6 months post treatmentSecondary outcomes
1
Identify imaging biomarkers of structural and biological changes after proton therapy
Descriptive statistics will be used to summarize the study data.
Time frame
Up to 24 months post-treatment2
Quantitative image biomarkers
Descriptive statistics will be used to summarize the study data.
Time frame
Up to 24 months post-treatment3
Validity of relative biological effectiveness models
Descriptive statistics will be used to summarize the study data.
Time frame
Up to 24 months post-treatment4
Incidence of late and acute toxicities
Descriptive statistics will be used to summarize the study data. For each study cohort, we will tabulate treatment- failures and other relevant clinically-related features. Interval estimates for proportions will be provided using exact 95% confidence intervals.
Time frame
Up to 24 months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov