The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.
As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
maintenance chemotherapy of maximum of 8 cycles á 42 days
Radiotherapy of the partial brain
Vivantes Netzwerk für Gesundheit GmbH
Berlin, Germany
Neurologische Universitätsklinik
Bochum, Germany
Universitätsklinikum Bonn
Bonn, Germany
feasibility of the adjuvant chemotherapy
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 and the kind of toxicity .
Time frame: participants will be followed for the duration of chemo therapy, an expected average of 1 year
Number of performable cycles in chemo therapy
It should be determined how many cycles in the maintenance chemotherapy are feasible.
Time frame: participants will be followed for the duration of chemo therapy, an expected average of 6 months
3 and 5 years progression-free survival
The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
event-free survival
The event-free survival (efs) should be determined for adult patients.
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
overall survival
The overall survival (os) should be determined for adult patients.
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
course of cognitive performance/QoL
The course of the cognitive performance and the quality of life should be observed.
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Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Otto-von-Guericke Universität
Magdeburg, Germany
Johannes Gutenberg-Universität Mainz
Mainz, Germany
...and 5 more locations
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years