Therapy of medulloblastoma of adults MedDRA version: 19.0 Level: PT Classification code 10027107 Term: Medulloblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Cisplatin
Product Name: Cisplatin
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Cisplatin
CAS Nu
Sponsors
Freistaat Bayern, represented by the University of Regensburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion is possible on attaining the age of 18. The intracranial tumor has to be a medulloblastoma. The tumor has to be first diagnosed at that time. The patient must not have received chemotherapy or radiotherapy yet. The Karnofsky-Score has to be at least 70%. The patient has to give a written consent. Pregnancy test has to be negative before baseline visit and has to be repeated every 4 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Inclusion is not possible for patients not having reached the age of 18. Inclusion is not possible in case of doubtful diagnosis. Relapse of a medulloblastoma that has already been treated with radiotherapy or chemotherapy. Investigator have to follow the summary of product characteristics (SmPC) for contraindications and safty warnings of the used substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far. The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity. In addition, the maximum number of cycles that are feasible shall be determined.;Secondary Objective: The secondary objectives refer to additional safety and efficacy parameters. It is aimed for a high probability of progression-free and event-free survival of adults with an intracranial medulloblastoma.;Primary end point(s): Primary end point is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far and therefore the maximum number of chemotherapy cycles that can be administered.; Timepoint(s) of evaluation of this end point: after 4 cycles of maintenance chemotherapy after end of treatment phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: after end of follow-up phase; Secondary end point(s): Determination of the number of feasible chemotherapy treatment blocks to be performed for adults Determination of the 3- and 5-year progression-free survival (PFS) rate for adult patients > 21 years of age (> 18 years) Determination of the event-free survival (EFS) rate for adult patients > 21 years of age (> 18 years) Determination of the overall survival (OS) rate for adult patients > 21 years of age (> 18 years) Comparison of progression-free survival (PFS) with the historic landmark comparison group from the HIT'91 Study receiving conventional radiation treatment Descriptive evaluation of imaging, histological and molecular parameters Progression of cognitive function, quality of life and social outcomes | — |
Countries
Germany
Contacts
Public ContactProf. Peter Hau
University of Regensburg Department Neurology
Outcome results
None listed