Phase II Study on Advanced Proton Therapy for Partially Removed Craniopharyngioma and Observation After Complete Removal

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT02792582

This study is exploring the use of a new type of radiation therapy, called intensity-modulated proton therapy, to treat craniopharyngioma, a rare brain tumor. The goal is to see if this therapy can effectively treat the tumor and reduce side effects compared to traditional radiation methods.

Patient Parameters

Program Overview

Craniopharyngioma is a rare brain tumor that can affect both children and adults. It develops near important areas of the brain, like the pituitary gland and visual pathways. Symptoms can include headaches, vision problems, and growth delays. Treatment often involves surgery, and sometimes radiation therapy if the tumor can't be completely removed. This study is testing a new form of radiation therapy called intensity-modulated proton therapy, which may have advantages over older methods. The main aim is to see if this therapy can effectively treat craniopharyngioma and reduce side effects.

Description

This study involves participants who have been diagnosed or are suspected to have craniopharyngioma based on brain scans or surgical evaluations. Participants may join the study before surgery if possible.

Primary Goal:

  • To see how well children and young adults with craniopharyngioma do after receiving intensity-modulated proton therapy, focusing on survival without tumor growth and monitoring for any serious brain or nerve issues.

Secondary Goals:

  • To track the need for further treatment of cysts and compare survival rates with those of patients treated with traditional radiation.
  • To compare outcomes for patients treated only with surgery to those who receive proton therapy.

Other Goals:

  • To explore how treatment affects brain function, hormone levels, and cognitive abilities.
  • To study sleep, fatigue, and quality of life in patients after treatment.
  • To evaluate physical abilities like balance and strength after treatment.
  • To use advanced imaging techniques to study the effects of treatment on the brain.
  • To explore the use of PET scans for verifying proton therapy doses.
  • To measure growth factors and other biological responses after treatment and compare them with traditional radiation therapy results.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with craniopharyngioma through tests or surgery.
  • Patients aged 0-21 years at diagnosis.

Exclusion Criteria

  • Previous radiation therapy.
  • Previous treatment with specific cyst-targeting drugs.
  • Pregnant females are not eligible due to potential risks from radiation.

Locations

FACILITYZIPCITYSTATE
St. Jude Children's Research Hospital38105MemphisTennessee

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