Prospective Study of Children and Adolescents With Craniopharyngioma

November 5, 2019 updated by: Prof. Dr. med. Hermann Mueller, Klinikum Oldenburg gGmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26133
        • Klinikum Oldenburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Radiation: Radiation
Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)
Other: Arm II
incomplete resection, wait and watch, MRI-controls every 3 months, and irradiation at the time of progression of residual tumor
Other: wait and watch
wait ans watch, MRI controls, irradiation at the time of progression of residual tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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).
3 years after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Progression or relapse
Time Frame: 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
3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Oldenburg gGmbH

Collaborators

Deutsche Kinderkrebsstiftung
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Deutsche Gesellschaft für Endokrinologie (DGE)
Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)
Deutsche Gesellschafr für Radioonkologie (DEGRO)
International Society of Paediatric Oncology

Investigators

  • Principal Investigator: Hermann L Müller, MD, Klinikum Oldenburg gGmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DKSR 463

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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