Prospective Study of Children and Adolescents With Craniopharyngioma

Conditions

Craniopharyngioma, Obesity

Keywords

Quality of life, Endocrinology, Oncology, Hypothalamus, Irradiation, Neurosurgery, Pediatric Brain tumors, Randomized trial

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.

Sowithayasakul P, Beckhaus J, Özyurt J, Bison B, Friedrich C, Müller HL.

2025-06-07

10.1007/s40618-025-02622-4

Daytime sleepiness and health-related quality of life in patients with childhood-onset craniopharyngioma.

Mann-Markutzyk LV, Beckhaus J, Özyurt J, Mehren A, Friedrich C, Müller HL.

2025-03-192 citations

10.1038/s41598-025-94384-5

Panjarat Sowithayasakul, Julia Beckhaus, Svenja Boekhoff, Carsten Friedrich, Gabriele Calaminus et al. (6 authors)

Scientific Reports2023-11-1017 citations

10.1038/s41598-023-46532-y

Outcome after proton beam therapy versus photon-based radiation therapy in childhood-onset craniopharyngioma patients—results of KRANIOPHARYNGEOM 2007

Carsten Friedrich, Svenja Boekhoff, Martin Bischoff, Julia Beckhaus, Panjarat Sowithayasakul et al. (13 authors)

Frontiers in Oncology2023-10-2719 citations

10.3389/fonc.2023.1180993

Sporadic and neurofibromatosis type 2-associated meningioma in children and adolescents.

Wagener K, Beckhaus J, Boekhoff S, Friedrich C, Müller HL.

2023-07-042 citations

10.1007/s11060-023-04344-0

Outcome after pediatric craniopharyngioma: the role of age at diagnosis and hypothalamic damage

Julia Beckhaus, Carsten Friedrich, Svenja Boekhoff, Gabriele Calaminus, Brigitte Bison et al. (9 authors)

European Journal of Endocrinology2023-02-2832 citations

10.1093/ejendo/lvad027

Craniopharyngiomas presenting as incidentalomas: results of KRANIOPHARYNGEOM 2007.

Boekhoff S, Bison B, Eveslage M, Sowithayasakul P, Müller HL.

2019-10-0117 citations

10.1007/s11102-019-00983-7

Oxytocin in survivors of childhood-onset craniopharyngioma.

Daubenbüchel AM, Hoffmann A, Eveslage M, Özyurt J, Lohle K, Reichel J, Thiel CM, Martens H, Geenen V, Müller HL.

2016-09-0155 citations

10.1007/s12020-016-1084-5

Fusiform dilatation of the internal carotid artery in childhood-onset craniopharyngioma: multicenter study on incidence and long-term outcome.

Hoffmann A, Warmuth-Metz M, Lohle K, Reichel J, Daubenbüchel AM, Sterkenburg AS, Müller HL.

2016-08-0119 citations

10.1007/s11102-016-0722-5

Interventions

RADIATIONRadiation

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

OTHERwait and watch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 18 Years

Healthy volunteers

No

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).

Design outcomes

Primary

Measure	Time frame	Description
Quality of life	3 years after diagnosis	•Randomized investigation of children (≥ 5 years of age) and adolescent QoL changes (main goal assessment) following incomplete craniopharyngioma resections at primary diagnosis per QoL endpoint scores (PEDQOL physical functions domain) measured from 3rd month after surgery for 3 years after randomization; and the progression-free and total survival rates (subgoal assessments) relative to how these rates relate to postoperative irradiation timing (immediate postsurgery irradiation versus wait-and-see approach + progression-contingent irradiation of residual tumor).

Secondary

Measure	Time frame	Description
Rate of Progression or relapse	3 years after surgery	* 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 * Evaluation of the health status (ophthalmologic, neuropsychologic and endocrine conditions) and health-related QoL of children and adolescents following treatment of craniopharyngiomas using data capture conforming to SIOP brain tumor groups

Countries

Germany

Outcome results

None listed