Prospective Study of Children and Adolescents With Craniopharyngioma

Klinikum Oldenburg gGmbH

Status: Completed

Conditions: Obesity; Craniopharyngioma

Treatments: Radiation: Radiation; Other: wait and watch

Study type: Interventional

Funder types: Other

Identifiers

NCT01272622

DKSR 463

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm I

Other group

Description:

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

Treatment:

Radiation: Radiation

Arm II

Other group

Description:

incomplete resection, wait and watch, MRI-controls every 3 months, and irradiation at the time of progression of residual tumor

Treatment:

Other: wait and watch