Prospective Study of Children and Adolescents With Craniopharyngioma

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272622
• Other study ID #: DKSR 463
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2019
• Source: Klinikum Oldenburg gGmbH
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 120
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 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).

Related Conditions & MeSH terms

• Craniopharyngioma
• Obesity

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

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