Prospective Study of Children and Adolescents With Craniopharyngioma

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

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

Sponsors & Collaborators

• German Society for Pediatric Oncology and Hematology GPOH gGmbH

  collaborator OTHER

• Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)

  collaborator UNKNOWN

• Deutsche Gesellschaft für Endokrinologie (DGE)

  collaborator UNKNOWN

• Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)

  collaborator UNKNOWN

• Deutsche Gesellschafr für Radioonkologie (DEGRO)

  collaborator UNKNOWN

• Deutsche Kinderkrebsstiftung

  collaborator OTHER

• International Society of Paediatric Oncology

  collaborator OTHER

• Klinikum Oldenburg gGmbH

  lead OTHER

Principal Investigators

• Hermann L Müller, MD · Klinikum Oldenburg gGmbH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• Germany

Study Locations