RT3CR: Proton Therapy for Pediatric Craniopharyngioma

A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection

  1. Brief Summary

    Craniopharyngioma is a brain tumor that most often arises in the suprasellar region and is intimately associated with the diencephalon, optic pathways and central cerebrovasculature. Standard treatments of surgery and radiation bring associated side effects which may be severe and long-lasting. Children with craniopharyngioma are at risk for physical performance limitations related to either their tumor or as a result of treatment. 

    This study will determine the feasibility and safety of treating craniopharyngioma using discrete spot-scanning proton therapy. When possible, patients will be enrolled on protocol prior to surgery to obtain pre- and post-operative clinical information. Proton therapy is an approved radiation therapy modality for treatment of this disease in children and has been shown to be superior to photon therapy in reducing dose to normal tissue. 

    Primary Objective

    • To estimate the distributions of progression-free and overall survival for children and young adults with craniopharyngioma treated with intensity-modulated proton therapy while monitoring for excessive central nervous system necrosis, clinically significant vasculopathy, and permanent neurological conditions or deficits

    Secondary Objectives include:

    • To compare disease control and functional outcomes for patients treated with primary surgery versus those treated with more limited or no surgery and proton therapy

    Eligibility Criteria

    Inclusion criteria include:

    • 21 years old or younger
    • Diagnosis of craniopharyngioma 

    Exclusion Criteria include:

    • History of fractionated radiation therapy
    • Treatment with intracystic P-32 or intracystic bleomycin
    • Currently pregnant

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this Study

    Craniopharyngioma is a rare brain tumor that most often affects children.  It often grows in an important area of the brain and may injure its vital parts. The results may be severe headache, loss of vision or impaired movement, body coordination and sensation.  It may also slow a child’s growth and development and can affect the balance of water and salts in the body.

    Standard treatment for this type of pediatric brain tumor may include radical surgery or limited surgery with radiation therapy. Radical surgery is when doctors successfully remove the tumor and no further treatment is needed. If radical surgery is not successful, radiation therapy is required.

    Patients who are not eligible for radical surgery may be treated with limited surgery. Limited surgery partially removes or treats the tumor to diagnose the disease or reduce the symptoms. After limited surgery, the patient receives radiation therapy.

    Surgery and radiation therapy have similar risks. Most of the side effects from surgery occur during or immediately following surgery. Most of the side effects from radiation therapy happen over time and can impact thinking, memory, behavior, growth, sleep and other bodily functions.

    Proton therapy is a new type of radiation therapy that targets pediatric brain tumors with high doses of radiation. Surrounding healthy tissues receive much less radiation from proton therapy than from standard radiation therapy. This precise targeting may reduce side effects. Proton therapy has been approved by the U.S. Food and Drug Administration for treatment of pediatric brain tumors.

    Purpose of this Clinical Trial

    The main goal of this study is to learn if proton therapy will treat patients with craniopharyngioma brain tumors effectively and reduce side effects compared to traditional forms of radiation therapy.

    Eligibility Overview

    • 21 years old or younger
    • Diagnosis of craniopharyngioma 
  3. RT3CR Quick View
    Sponsors St. Jude Children's Research Hospital
    ClinicalTrials.gov identifier NCT02792582
    Trial Start Date June 2016
    Estimated Enrollment 140
    Study Type Interventional
    Study Phase Phase II
    Conditions Craniopharyngioma
    Ages 21 years old and younger
    Principal investigator Thomas Merchant, DO, PhD
    Study Sites St. Jude Children’s Research Hospital 
    For a consultation or to discuss RT3CR St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Thomas Merchant, DO, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.