Kraniopharyngeom 2007
Author: Ursel Gebhard, Julia Dobke, erstellt am: 2007/05/25,
Last modification: 2011/09/19
Kraniopharyngeom 2007 |
Kraniopharyngeom 2007: Multicenter Prospective Study
of Children and Adolescents with Craniopharyngioma |
Disease |
Children and adolescents with craniopharyngioma |
Type |
Prospective, multicentre therapy- and treatment study |
Problem / Objectives |
- Randomized investigation of changes in Quality of life (QoL) of children (≥ 5 years of age) and adolescents following incomplete craniopharyngioma resections at primary diagnosis per QoL scores (PEDQOL "physical functions" domain) as measured 60-90 days after surgery and 3 years after randomization; and progression-free and overall survival rates (subgoal assessments) relative to how these parameters relate to postoperative irradiation timing (immediate postsurgery irradiation versus wait-and-see approach + progression-contingent irradiation of residual tumor).
- Compilation of applied therapy strategies for craniopharyngiomas in children and adolescents using data capture conforming to SIOP brain tumor groups
- Evaluation of patients’ remission status following the various therapy strategies/modalities for craniopharyngiomas using data detection consistent with SIOP brain tumor groups
- Investigation of frequency of patients with adenoma of the hypophysis and meningiomas, xanthogranulomas and of sellar and parasellar cystic deformities (arachnoid cysts and Rathke’s pouch cysts)
|
Therapy / Study arms |
Patients with incomplete resection and age >= 5 years will be randomized in two treatment arms:
• Arm I: Planning of localized XRT immediately following surgery (after randomization)
• Arm II: At sign of progression (>25%): localized XRT, (if needed after subsequent surgery) and reference assessment of XRT plans
Patients with complete resection or incomplete resection and age <= 5 years:
• Continuous observation in KRANIOPHARYNGEOM Surveillance Study
|
Inclusion Criteria |
1. Histological diagnosis of the craniopharyngioma
2. Age at diagnosis ≤ 18 years of age
3. Agreement from patient’s parents or legal guardian as well as the patient
For the randomization:
1. Age at primary surgery ≥ 5 years of age
2. Incomplete primary resection
3. Reference radiological confirmation of an incomplete resection
4. Agreement from patient’s parents or legal guardian as well as the patient
|
Exclusion Criteria |
No QoL measurement for randomization (3 months after surgery, 60−90 days).
|
Recruitment |
150 |
Status |
01.10.2007 - 30.09.2013 |
EudraCT |
Keine BfArM-Studie
|
Entry Study Register |
|
Principal Investigator |
Prof. Dr. med. Hermann L. Müller |
E-Mail |
kikra.doku@klinikum-oldenburg.de
|
Contact |
Principal Investigator
PD Dr. med.
Carsten Friedrich
Klinikum Oldenburg AöR, Universitätskinderklinik für Kinder- und Jugendmedizin
Abteilung für Allgemeine Pädiatrie, Pädiatrische Hämatologie / Onkologie
Rahel-Straus-Str. 10
26133
Oldenburg
Telefon +49 (441) 403 70708
Fax +49 (441) 403 12623
friedrich.carsten@klinikum-oldenburg.de
Documentation
Ursel Gebhardt
Klinikum Oldenburg gGmbH, Zentrum für Kinder- und Jugendmedizin
Päd. Hämatologie/Onkologie, Studienzentrale Kraniopharyngeom
Rahel-Straus-Str. 10
26133
Oldenburg
Telefon +49 (441) 403 2072
Fax +49 (441) 403 2789
kikra.doku@klinikum-oldenburg.de
|
Weitere Informationen |
Certified by the German Cancer Society (Seal of Approval A) |
Documents |
|
Link(s) |
Trial literature on cranyopharingeoma
|
Sponsoring |
Deutsche Kinderkrebsstiftung, Bonn |