Prospective Study of Children and Adolescents With Craniopharyngioma

Not Applicable

Completed

• Conditions: Obesity; Craniopharyngioma
• Interventions: Radiation: Radiation; Other: wait and watch

• Registration Number: NCT01272622
• Lead Sponsor: Klinikum Oldenburg gGmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	Radiation	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
Arm II	wait and watch	incomplete resection, wait and watch, MRI-controls every 3 months, and irradiation at the time of progression of residual tumor

Primary Outcome Measures

Name	Time	Method
Quality of life	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).

Secondary Outcome Measures

Name	Time	Method
Rate of Progression or relapse	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

Trial Locations

Locations (1)

Klinikum Oldenburg; 🇩🇪 Oldenburg, Niedersachsen, Germany