CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 361 enrolled
Drug / intervention
Radiation Therapy +1 moreprocedure
Likely dose
54 Gy at 1.8 Gy per day (low-grade glioma, craniopharyngioma, selected ependymoma) or 59.4 Gy at 1.8 Gy per day (high-grade glioma, selected ependymoma)AI-extracted
Key inclusion· 4
  • Age at least 8 months and at most 25 years at time of irradiation
  • Histologically confirmed craniopharyngioma, ependymoma, low-grade astrocytoma, or high-grade glioma (or radiographically diagnosed craniopharyngioma/low-grade glioma in selected patients)
  • Tumor type requires only focal irradiation
  • No prior fractionated external beam radiation therapy
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00187226
NCT00187226Phase 2Completed

A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects

St. Jude Children's Research Hospital·interventional·Posted Sep 16, 2005·Updated May 31, 2023

In Brief

A Phase 2 clinical trial evaluating Radiation Therapy for Central Nervous System Tumors and Brain Tumors. Completed, enrolled 361 participants across 1 site.

Detailed Summary

The purpose of the study was to determine if treating a limited volume of normal tissue surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar rates of disease control compared to standard radiation therapy. The study was also conducted to examine the effect of irradiation on neurological, endocrine and cognitive function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJun 1, 1997
Primary CompletionMar 31, 2005
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 20.8 years ago

Interventions

Radiation Therapyprocedure

External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.

Radiation Therapyprocedure

External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.