Prospective Study of Children and Adolescents With Craniopharyngioma

NCT ID: NCT01272622

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2019-09-30

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.

Conditions

Craniopharyngioma; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Children and adolescents >= 18 years of age new diagnosed with craniopharyngioma

• >= 5 years of age and with incomplete resected tumor => randomized in two arms: immediate irradiation after surgery

Group Type: OTHER

Radiation

Intervention Type: RADIATION

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

Arm II

incomplete resection, wait and watch, MRI-controls every 3 months, and irradiation at the time of progression of residual tumor

Group Type: OTHER

wait and watch

Intervention Type: OTHER

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

Interventions

Radiation

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

Intervention Type: RADIATION

wait and watch

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Society for Pediatric Oncology and Hematology GPOH gGmbH

OTHER

Sponsor Role: collaborator

Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)

UNKNOWN

Sponsor Role: collaborator

Deutsche Gesellschaft für Endokrinologie (DGE)

UNKNOWN

Sponsor Role: collaborator

Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)

UNKNOWN

Sponsor Role: collaborator

Deutsche Gesellschafr für Radioonkologie (DEGRO)

UNKNOWN

Sponsor Role: collaborator

Deutsche Kinderkrebsstiftung

OTHER

Sponsor Role: collaborator

International Society of Paediatric Oncology

OTHER

Sponsor Role: collaborator

Klinikum Oldenburg gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Hermann Mueller

Professor MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hermann L Müller, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Oldenburg gGmbH

Locations

Klinikum Oldenburg

Oldenburg, Lower Saxony, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40481916 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40108339 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37965466 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37949931 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37402092 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36857103 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31440945 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27585663 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27125511 (View on PubMed)

Other Identifiers

DKSR 463

Identifier Type: -

Identifier Source: org_study_id