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Prospective Study of Children and Adolescents With Craniopharyngioma

K

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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