NCT01272622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

12 years

First QC Date

January 7, 2011

Last Update Submit

November 5, 2019

Conditions

CraniopharyngiomaObesity

Keywords

Quality of lifeEndocrinologyOncologyHypothalamusIrradiationNeurosurgeryPediatric Brain tumorsRandomized trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Rate of Progression or relapse

    3 years after surgery

Study Arms (2)

Arm I

OTHER

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

Radiation: Radiation

Arm II

OTHER

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

Other: wait and watch

Interventions

RadiationRADIATION

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

Arm I
wait and watchOTHER

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

Arm II

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed with craniopharyngioma for the first time
  • Age at diagnosis 18 years or less of age
  • Agreement from patient's parents or legal guardian as well as the patient
  • Histological diagnosis of craniopharyngioma
  • Age at diagnosis 18 years or less of age
  • Age at primary surgery over 5 years of age
  • Incomplete primary resection
  • Reference radiological confirmation of an incomplete resection
  • Agreement from patient's parents or legal guardian as well as the patient

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Oldenburg

Oldenburg, Lower Saxony, 26133, Germany

Location

Related Publications (9)

  • 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.

    PMID: 40481916DERIVED

  • 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.

    PMID: 40108339DERIVED

  • 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.

    PMID: 37965466DERIVED

  • 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.

    PMID: 37949931DERIVED

  • 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.

    PMID: 37402092DERIVED

  • 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.

    PMID: 36857103DERIVED

  • 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.

    PMID: 31440945DERIVED

  • 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.

    PMID: 27585663DERIVED

  • 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.

    PMID: 27125511DERIVED

MeSH Terms

Conditions

CraniopharyngiomaObesityNeoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Hermann L Müller, MD

    Klinikum Oldenburg gGmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor MD

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 10, 2011

Study Start

October 1, 2007

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations

DE(1)