KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma
N/A
18 Years
Both
Craniopharyngioma, Obesity
Trial Information
KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Quality of life
Outcome Description:
•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).
Outcome Time Frame:
3 years after diagnosis
Safety Issue:
Yes
Authority:
Germany: Ethical board
Study ID:
DKSR 463
NCT ID:
NCT01272622
Start Date:
October 2007
Completion Date:
April 2014
Related Keywords:
- Craniopharyngioma
- Obesity
- Quality of life
- Endocrinology
- Oncology
- Hypothalamus
- Irradiation
- Neurosurgery
- Pediatric Brain tumors
- Randomized trial
- Craniopharyngioma
- Adamantinoma
- Obesity
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