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CraniopharyngiomaNCT01272622

Prospective Study of Children and Adolescents With Craniopharyngioma

A study testing Radiation and wait and watch in people with Craniopharyngioma and Obesity, run by Klinikum Oldenburg gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 day to 18 years
Conditions the study is for
Craniopharyngioma, Obesity
What is being tested?
Radiation and wait and watch
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteGermany
Study dates
Oct 2007to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
  • Criteria for inclusion in randomization study
  • Histological diagnosis of craniopharyngioma
  • Age at diagnosis 18 years or less of age
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum Oldenburg

    Oldenburg, Lower Saxony, 26133

Other trials in Germany

About this study

Official title: KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma

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.

Being tested
Radiation, wait and watch
Keywords
Quality of life, Endocrinology, Oncology, Hypothalamus, Irradiation, Neurosurgery, Pediatric Brain tumors, Randomized trial
Medical subject headings
Craniopharyngioma, Obesity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiationRadiation

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

  • wait and watchOther

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

Study groups in NCT01272622
Study groupRoleWhat they receive
Arm IOtherChildren 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
Receives: Radiation: Radiation
Arm IIOtherincomplete resection, wait and watch, MRI-controls every 3 months, and irradiation at the time of progression of residual tumor
Receives: Other: wait and watch

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 years after diagnosis

Secondary outcomes (1)

  1. Rate of Progression or relapse

    • 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

    Measured: 3 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2011 (estimated)
  2. Study startOct 2007
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01272622
Sponsor's protocol ID
DKSR 463
Status last verified
Nov 2019
First submitted
7 Jan 2011
Last updated
6 Nov 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40481916

  • 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.

    PubMed 40108339

  • Beckhaus J, Peng J, Boekhoff S, Bison B, Friedrich C, Muller HL. Head circumferences measured during developmental monitoring visits before diagnosis of childhood-onset craniopharyngioma. PLoS One. 2024 Jul 23;19(7):e0307395. doi: 10.1371/journal.pone.0307395. eCollection 2024.

    PubMed 39042636

  • 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.

    PubMed 37965466

  • 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.

    PubMed 37949931

  • 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.

    PubMed 37402092

  • 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.

    PubMed 36857103

  • 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.

    PubMed 31440945

  • 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.

    PubMed 27585663

  • 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.

    PubMed 27125511

Questions about this trial

What is this clinical trial studying?

A study testing Radiation and wait and watch in people with Craniopharyngioma and Obesity, run by Klinikum Oldenburg gGmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: 3 years after diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272622, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.

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