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A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Craniopharyngioma

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Trial Information

A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection


The primary objectives of this study :

To estimate the progression-free and overall survival distributions for children and young
adults with craniopharyngioma treated with limited surgery and proton therapy using a 5mm
clinical target volume margin while monitoring for excessive central nervous system
necrosis.

The Secondary Objectives of this study:

- To estimate the cumulative incidence of cystic intervention and the event-free survival
distribution for children and young adults with craniopharyngioma treated with limited
surgery and proton therapy using a 5mm clinical target volume margin; and compare the
distributions of progression-free, event-free and overall survival with the
distributions for the St. Jude Children's Research Hospital cohort of 93 patients on
which the design of this trial is based.

- To estimate the distributions of progression-free survival and overall survival for
children and young adults with craniopharyngioma treated only with primary surgical
resection and to compare these distributions with the distributions observed for
patients treated with limited surgery and proton therapy.


Inclusion Criteria:



- Craniopharyngioma diagnosed by histology, cytology or neuroimaging.

- Patients ages 0-21 years at the time of diagnosis.

Exclusion Criteria

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton therapy

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Thomas E Merchant, DO, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

RT2CR

NCT ID:

NCT01419067

Start Date:

August 2011

Completion Date:

August 2022

Related Keywords:

  • Craniopharyngioma
  • Proton Therapy
  • Radical resection
  • Craniopharyngioma
  • Adamantinoma

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
University of Florida Proton Therapy InstituteJacksonville, Florida  32206