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NCT03750513 · ClinicalTrials.gov registry record · Phase 1
LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
A Phase 1 study of Ependymoma and Anaplastic Ependymoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT03750513: Recruiting Phase 1 study of Ependymoma and Anaplastic Ependymoma, sponsored by M.D. Anderson Cancer Center.
NCT03750513 is a Phase 1 study of Ependymoma and Anaplastic Ependymoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 48 participants, below the 102-participant average among 20 other Ependymoma trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03750513, a Phase 1 study of Ependymoma and Anaplastic Ependymoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Study Locations (2)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT03750513 shows while recruiting
NCT03750513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 102-participant average among 20 other Ependymoma trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Ependymoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03750513 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT03750513 about?
NCT03750513 is a clinical study titled "LET Optimized IMPT in Treating Pediatric Patients With Ependymoma". 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 surroundi...
What is the current status of trial NCT03750513?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-04-01. Estimated completion is 2027-12-31.
What conditions does trial NCT03750513 study?
This clinical trial studies the following conditions: Ependymoma, Anaplastic Ependymoma.
What interventions are being tested in trial NCT03750513?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy (RADIATION).
Who is sponsoring clinical trial NCT03750513?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03750513 being conducted?
This trial has 2 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ependymoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03750513's enrollment target sits among peer trials
48 13th of 20 higher than 7 of 20 other Ependymoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ependymoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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