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NCT02125786 · ClinicalTrials.gov registry record · Phase 2
A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
A Phase 2 study of Ependymoma, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT02125786: Active Phase 2 study of Ependymoma, sponsored by St. Jude Children's Research Hospital.
NCT02125786 is a Phase 2 study of Ependymoma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 68 participants, below the 101-participant average among 20 other Ependymoma trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02125786, a Phase 2 study of Ependymoma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this study is to investigate whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment. The combined doses of the first and second courses of radiation are higher than what is usual standard of care. The investigators will study the effects and side effects of surgery and re-irradiation. They will also evaluate and study tumor tissue and blood to learn more about the tumor and how it does or does not respond to treatments and will use magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to see if they can predict tumor response and tumor recurrence. Participants will be followed for up to 5 years following enrollment. Evaluations during radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and every 6 months during the 4th and 5th year.
Primary Outcome
To prospectively estimate the progression-free distribution for children and young adults with recurrent ependymoma treated with a second course of irradiation.
Conditions Studied
Interventions
- PROCEDURE Surgery
- RADIATION Irradiation
- DRUG ^1^8F-Fluorodeoxyglucose
- DRUG ^1^1C-methionine
- DEVICE Photon therapy
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2014-05-07 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What the registry record for NCT02125786 still lists
NCT02125786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 101-participant average among 20 other Ependymoma trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Ependymoma appearing as the primary indexed condition, and to 5 interventions - of which Surgery is the first listed.
NCT02125786 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02125786 about?
NCT02125786 is a clinical study titled "A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma". The primary purpose of this study is to investigate whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment. The combined doses of the first and second courses of radiation are higher than what is usual standard of care. The investigators will study t...
What is the current status of trial NCT02125786?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2014-05-07. Estimated completion is 2028-05.
What conditions does trial NCT02125786 study?
This clinical trial studies the following conditions: Ependymoma.
What interventions are being tested in trial NCT02125786?
The interventions under investigation include: Surgery (PROCEDURE), Irradiation (RADIATION), ^1^8F-Fluorodeoxyglucose (DRUG), ^1^1C-methionine (DRUG), Photon therapy (DEVICE).
Who is sponsoring clinical trial NCT02125786?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02125786 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02125786's enrollment target sits among peer trials
68 10th of 20 higher than 11 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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