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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01272622
Other study ID # DKSR 463
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2007
Est. completion date March 2019

Study information

Verified date August 2018
Source Klinikum Oldenburg gGmbH
Contact Hermann L Mueller, MD
Phone +49 441 403
Email mueller.hermann@klinikum-oldenburg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Radiation:
Radiation
Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)
Other:
wait and watch
wait ans watch, MRI controls, irradiation at the time of progression of residual tumor

Locations

Country Name City State
Germany Klinikum Oldenburg Oldenburg Niedersachsen

Sponsors (8)

Lead Sponsor Collaborator
Klinikum Oldenburg gGmbH Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE), Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO), Deutsche Gesellschafr für Radioonkologie (DEGRO), Deutsche Gesellschaft für Endokrinologie (DGE), Deutsche Kinderkrebsstiftung, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany, International Society of Paediatric Oncology (SIOP)

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
3 years after surgery
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