Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003779

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003779
  •   2012/04/30
  •   2011/01/07
  •   yes
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Secondary IDs

  •   NCT01272622  (ClinicalTrials.gov)
  •   DKSR 463  (Klinikum Oldenburg gGmbH)
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Health Condition or Problem studied

  •   Craniopharyngioma
  •   Obesity
  •   D44.4 -  Neoplasm of uncertain or unknown behaviour: Craniopharyngeal duct
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Interventions/Observational Groups

  •   Radiation: Radiation
  •   Other: wait and watch
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- 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).

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2007/10/31
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   18   Years
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Additional 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

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Exclusion Criteria

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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum Oldenburg gGmbH
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    •   [---]*
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    • Hermann L Mueller, MD 
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    • Hermann L Mueller, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   111
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.