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

St. Jude Children's Research Hospital

Status and phase: Active, not recruiting; Phase 2

Conditions: Craniopharyngioma

Treatments: Drug: ^1^1C-methionine; Procedure: Radical Surgery or Limited Surgery; Device: Proton Therapy; Drug: ^1^8F-fluorodeoxyglucose

Study type: Interventional

Funder types: Other

Identifiers

NCT01419067

NCI-2011-03707 (Registry Identifier)

RT2CR

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 112 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Craniopharyngioma Patients

Other group

Description:

Craniopharyngioma patients will have 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). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine will be given to aid in tumor visualization.

Treatment:

Drug: ^1^8F-fluorodeoxyglucose

Device: Proton Therapy

Procedure: Radical Surgery or Limited Surgery

Drug: ^1^1C-methionine