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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vincristin, CCNU, cis-platin | Experimental | radiotherapy and concomitant chemotherapy (7 cycles of 7 days):
maintenance chemotherapy (8 cycles of 42 days):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maintenance chemotherapy (vincristin, cisplatin and CCNU) | Drug | maintenance chemotherapy of maximum of 8 cycles á 42 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | participants will be followed for the duration of chemo therapy, an expected average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of performable cycles in chemo therapy | It should be determined how many cycles in the maintenance chemotherapy are feasible. | participants will be followed for the duration of chemo therapy, an expected average of 6 months |
| 3 and 5 years progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hau, MD | Department of Neurology, University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivantes Netzwerk für Gesundheit GmbH | Berlin | 10249 | Germany | |||
| Neurologische Universitätsklinik |
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| Radiotherapy | Radiation | Radiotherapy of the partial brain |
|
The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients. |
| 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. | 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. | 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. | participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years |
| Bochum |
| 44892 |
| Germany |
| Universitätsklinikum Bonn | Bonn | 53105 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Otto-von-Guericke Universität | Magdeburg | 39120 | Germany |
| Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Katharinenhospital | Stuttgart | 70174 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| ID | Term |
|---|---|
| D008527 | Medulloblastoma |
| D009369 | Neoplasms |
| D017599 | Neuroectodermal Tumors |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D060046 | Maintenance Chemotherapy |
| D014750 | Vincristine |
| D002945 | Cisplatin |
| D008130 | Lomustine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
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