Clinical trial NCT01272622: Prospective Study of Children and Adolescents With Craniopharyngioma
Official title: KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniopharyngioma
Obesity
Keywords: Quality of life
Endocrinology
Oncology
Hypothalamus
Irradiation
Neurosurgery
Pediatric Brain tumors
Randomized trial
Lead sponsor: Klinikum Oldenburg gGmbH
Sponsor class: OTHER
Collaborators: name: German Society for Pediatric Oncology and Hematology GPOH gGmbH
name: Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)
name: Deutsche Gesellschaft für Endokrinologie (DGE)
name: Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
name: Deutsche Gesellschafr für Radioonkologie (DEGRO)
name: Deutsche Kinderkrebsstiftung
name: International Society of Paediatric Oncology
First posted: 2011-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with craniopharyngioma for the first time
2. Age at diagnosis 18 years or less of age
3. Agreement from patient's parents or legal guardian as well as the patient

Criteria for inclusion in randomization study

1. Histological diagnosis of craniopharyngioma
2. Age at diagnosis 18 years or less of age
3. Age at primary surgery over 5 years of age
4. Incomplete primary resection
5. Reference radiological confirmation of an incomplete resection
6. Agreement from patient's parents or legal guardian as well as the patient

Exclusion Criteria:

Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery).

Primary outcomes:
measure: Quality of life
timeFrame: 3 years after diagnosis
Secondary outcomes:
measure: Rate of Progression or relapse
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
state: Niedersachsen
Study officials:
affiliation: Klinikum Oldenburg gGmbH
name: Hermann L Müller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boekhoff S, Bison B, Eveslage M, Sowithayasakul P, Muller HL. Craniopharyngiomas presenting as incidentalomas: results of KRANIOPHARYNGEOM 2007. Pituitary. 2019 Oct;22(5):532-541. doi: 10.1007/s11102-019-00983-7.
citation: Daubenbuchel AM, Hoffmann A, Eveslage M, Ozyurt J, Lohle K, Reichel J, Thiel CM, Martens H, Geenen V, Muller HL. Oxytocin in survivors of childhood-onset craniopharyngioma. Endocrine. 2016 Nov;54(2):524-531. doi: 10.1007/s12020-016-1084-5. Epub 2016 Sep 1.
citation: Hoffmann A, Warmuth-Metz M, Lohle K, Reichel J, Daubenbuchel AM, Sterkenburg AS, Muller HL. Fusiform dilatation of the internal carotid artery in childhood-onset craniopharyngioma: multicenter study on incidence and long-term outcome. Pituitary. 2016 Aug;19(4):422-8. doi: 10.1007/s11102-016-0722-5.