CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Radiation +1 moreradiation
Likely dose
Not stated in record
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Search/NCT01272622
NCT01272622N/ACompleted

KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma

Klinikum Oldenburg gGmbH·interventional·Posted Jan 10, 2011·Updated Nov 6, 2019

In Brief

A clinical study evaluating Radiation and wait and watch for Craniopharyngioma and Obesity. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.

Study Details

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2011
Enrollment StartOct 1, 2007
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 12.0 yearsPosted 15.5 years ago

Interventions

Radiationradiation

Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)

wait and watchother

wait ans watch, MRI controls, irradiation at the time of progression of residual tumor