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NCT01419067 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection
A Phase 2 study of Craniopharyngioma, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
- 2
- Study locations
NCT01419067: Active Phase 2 study of Craniopharyngioma, sponsored by St. Jude Children's Research Hospital.
NCT01419067 is a Phase 2 study of Craniopharyngioma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 112 participants, below the 198-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (43% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01419067, a Phase 2 study of Craniopharyngioma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this study is to determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume margin in combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Irradiated patients will undergo a series of evaluations designed to evaluate the effects of proton therapy. Similar evaluations will be performed on patients treated with radical surgery. Proton therapy will include 30 treatment fractions administered 5 days per week. Weekly imaging will be a requirement to monitor for cyst expansion and target volume deformation.
Primary Outcome
Reducing the clinical target volume margin to 5mm and using proton therapy, with the goal of reducing side effects from irradiation, will not increase the rate of tumor progression compared to photon therapy with a similar or larger clinical target volume margin.
Conditions Studied
Interventions
- DEVICE Proton Therapy
- DRUG ^1^1C-methionine
- PROCEDURE Radical Surgery or Limited Surgery
- DRUG ^1^8F-fluorodeoxyglucose
Study Locations (2)
Florida
- University of Florida Health Proton Therapy Institute - Jacksonville
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2011-08-22 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
What the registry record for NCT01419067 still lists
NCT01419067 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 198-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Craniopharyngioma appearing as the primary indexed condition, and to 4 interventions - of which Proton Therapy is the first listed.
NCT01419067 reports a single indexed study location in Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01419067 about?
NCT01419067 is a clinical study titled "A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection". The goal of this study is to determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume margin in combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopha...
What is the current status of trial NCT01419067?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2011-08-22. Estimated completion is 2026-07.
What conditions does trial NCT01419067 study?
This clinical trial studies the following conditions: Craniopharyngioma.
What interventions are being tested in trial NCT01419067?
The interventions under investigation include: Proton Therapy (DEVICE), ^1^1C-methionine (DRUG), Radical Surgery or Limited Surgery (PROCEDURE), ^1^8F-fluorodeoxyglucose (DRUG).
Who is sponsoring clinical trial NCT01419067?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419067 being conducted?
This trial has 2 study locations across Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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