NCT01419067Active, not recruitingPhase 2
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 16 Aug 2011
- Start date
- 22 Aug 2011
- Primary completion date
- 30 Jun 2031
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT01419067
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 112
- From 22 Aug 2011 to the primary completion date, 30 Jun 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of fractionated radiation therapy.
- Prior treatment with intracystic P-32, intracystic bleomycin or radiosurgery.
- Pregnant females are excluded. Radiation has teratogenic or abortifacient effects.
Who the study is looking for
- Craniopharyngioma diagnosed by histology, cytology or neuroimaging.
- Patients ages 0-21 years at the time of diagnosis.
Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Health Proton Therapy Institute Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.