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| Name | Class |
|---|---|
| German Society for Pediatric Oncology and Hematology GPOH gGmbH | OTHER |
| Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE) | UNKNOWN |
| Deutsche Gesellschaft für Endokrinologie (DGE) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Other | Children and adolescents >= 18 years of age new diagnosed with craniopharyngioma
|
|
| Arm II | Other | incomplete resection, wait and watch, MRI-controls every 3 months, and irradiation at the time of progression of residual tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | •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). | 3 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Progression or relapse |
|
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Inclusion Criteria:
Criteria for inclusion in randomization study
Exclusion Criteria:
Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery).
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| Name | Affiliation | Role |
|---|---|---|
| Hermann L Müller, MD | Klinikum Oldenburg gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Oldenburg | Oldenburg | Lower Saxony | 26133 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40481916 | Derived | Sowithayasakul P, Beckhaus J, Ozyurt J, Bison B, Friedrich C, Muller HL. Prolactin serum concentrations in childhood-onset craniopharyngioma patients. J Endocrinol Invest. 2025 Sep;48(9):2041-2051. doi: 10.1007/s40618-025-02622-4. Epub 2025 Jun 7. | |
| 40108339 | Derived | Mann-Markutzyk LV, Beckhaus J, Ozyurt J, Mehren A, Friedrich C, Muller HL. Daytime sleepiness and health-related quality of life in patients with childhood-onset craniopharyngioma. Sci Rep. 2025 Mar 19;15(1):9407. doi: 10.1038/s41598-025-94384-5. |
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| ID | Term |
|---|---|
| D003397 | Craniopharyngioma |
| D009765 | Obesity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO) | UNKNOWN |
| Deutsche Gesellschafr für Radioonkologie (DEGRO) | UNKNOWN |
| Deutsche Kinderkrebsstiftung | OTHER |
| International Society of Paediatric Oncology | OTHER |
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| wait and watch | Other | wait ans watch, MRI controls, irradiation at the time of progression of residual tumor |
|
| 3 years after surgery |
| 37965466 | Derived | Friedrich C, Boekhoff S, Bischoff M, Beckhaus J, Sowithayasakul P, Calaminus G, Eveslage M, Valentini C, Bison B, Harrabi SB, Krause M, Timmermann B, Muller HL. Outcome after proton beam therapy versus photon-based radiation therapy in childhood-onset craniopharyngioma patients-results of KRANIOPHARYNGEOM 2007. Front Oncol. 2023 Oct 27;13:1180993. doi: 10.3389/fonc.2023.1180993. eCollection 2023. |
| 37949931 | Derived | Sowithayasakul P, Beckhaus J, Boekhoff S, Friedrich C, Calaminus G, Muller HL. Vision-related quality of life in patients with childhood-onset craniopharyngioma. Sci Rep. 2023 Nov 10;13(1):19599. doi: 10.1038/s41598-023-46532-y. |
| 37402092 | Derived | Wagener K, Beckhaus J, Boekhoff S, Friedrich C, Muller HL. Sporadic and neurofibromatosis type 2-associated meningioma in children and adolescents. J Neurooncol. 2023 Jul;163(3):555-563. doi: 10.1007/s11060-023-04344-0. Epub 2023 Jul 4. |
| 36857103 | Derived | Beckhaus J, Friedrich C, Boekhoff S, Calaminus G, Bison B, Eveslage M, Timmermann B, Flitsch J, Muller HL. Outcome after pediatric craniopharyngioma: the role of age at diagnosis and hypothalamic damage. Eur J Endocrinol. 2023 Mar 2;188(3):lvad027. doi: 10.1093/ejendo/lvad027. |
| 31440945 | Derived | 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. |
| 27585663 | Derived | 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. |
| 27125511 | Derived | 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. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |