NCT01272622

Prospective Study of Children and Adolescents With Craniopharyngioma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Klinikum Oldenburg gGmbH · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Craniopharyngioma
• Obesity

Interventions

Type	Name	Description
RADIATION	Radiation	Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)
OTHER	wait and watch	wait ans watch, MRI controls, irradiation at the time of progression of residual tumor

Timeline

• Start date: 2007-10-01
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2011-01-10
• Last updated: 2019-11-06

Locations

1 site across 1 country: Germany