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| Name | Class |
|---|---|
| University Hospital, Bordeaux | OTHER |
| Centre Paul Strauss | OTHER |
| Centre Hospitalier Universitaire de Nice | OTHER |
| CRLCC Val d'Aurelle, Montpellier |
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Adult medulloblastoma is a rare tumour.
The "standard risk " group (complete surgery or residual tumour lower than 1,5 cm2, absence of malignant cells in the cerebrospinal fluid, absence of metastasis, absence of MYC amplification and exclusion of large cells medulloblastoma) concerns, for the adult population, a majority of patients at diagnosis (about ¾ of cases).
Conventional treatment is classically based on a 54/36 Gy cranio-spinal radiotherapy (54 Gy on the posterior fossa and 36 Gy on the nevraxis).
This treatment is associated with an acute toxicity (haematological, cutaneous, digestive and general) wich decreases gradually when patient goes away from the treatment period.
For this category of patients and this modality of treatment, The French intergroup experience, pleads in favour of a late and progressive neurotoxicity.
This neurotoxicity is associated with a clear degradation of the quality of life.
In the light of paediatric studies :
We propose a phase II study to estimate the interest of a decrease of radiation doses compensated by a chemotherapy according to the following schedule
The majority of French centres concerned with the neuro-oncology are involved in this trial.
About 25 new cases by year are waited. A centralized analysis of pathological slides and of the pre and post surgery Magnetic Resonance Imaging is foreseen.
The main objective is to estimate the survival without disease at 1 year
Secondary objectives associate the evaluations of the rate of complete response at the end of procedure, the overall survival, the survival without disease, the survival without events, the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the time until definitive deterioration of the quality of life Associated studies
Two associated studies are besides foreseen (parallel search for co-financing):
A biologic study is planed with the aim to confirm, by morphological, genomic and transcriptomic studies, the interest, for the adult population, of the prognostic markers used in paediatric population
A radiological study is planed with the aim to estimate the interest :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teatment arm | Experimental | carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatine | Drug | carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed |
|
| Measure | Description | Time Frame |
|---|---|---|
| survival without disease at 1 year | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luc TAILLANDIER | Contact | +33 3 83 85 16 88 | l.taillandier@chu-nancy.fr | |
| Charlotte CARNIN | Contact | +33 3 83 85 95 92 | c.carnin@chu-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Luc TAILLANDIER | CHU NANCY - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Not yet recruiting | Amiens | 80053 | France |
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| UNKNOWN |
| Centre Georges Francois Leclerc | OTHER |
| Gustave Roussy, Cancer Campus, Grand Paris | OTHER |
| Centre Leon Berard | OTHER |
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
| Hôpital de la Timone | OTHER |
| CHU de Reims | OTHER |
| Hopitaux Civils de Colmar | OTHER |
| University Hospital, Lille | OTHER |
| Institut Claudius Regaud | OTHER |
| Centre Francois Baclesse | OTHER |
| Center Eugene Marquis | OTHER |
| Centre René Gauducheau | OTHER |
| Centre Hospitalier Universitaire, Amiens | OTHER |
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| Etoposide | Drug | carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed |
|
| radiation therapy | Radiation | carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed |
|
| Chu Bordeaux | Not yet recruiting | Bordeaux | 33075 | France |
|
| CHU CAEN | Not yet recruiting | Caen | 14000 | France |
|
| Hopitaux Civils de Colmar | Not yet recruiting | Colmar | 68024 | France |
|
| Cenre Georges Francois Leclerc | Not yet recruiting | Dijon | 21079 | France |
|
| Chru de Lille | Recruiting | Lille | 59037 | France |
|
| Centre Leon Berrard | Not yet recruiting | Lyon | 69373 | France |
|
| Hopital de La Timone | Not yet recruiting | Marseille | 13385 | France |
|
| Centre Val D'Aurelle | Not yet recruiting | Montpellier | 34298 | France |
|
| Chu Nancy | Recruiting | Nancy | 54000 | France |
|
| Centre René Ganducheau | Not yet recruiting | Nantes | 44805 | France |
|
| Chu de Nice | Not yet recruiting | Nice | 06002 | France |
|
| Chu Nimes | Not yet recruiting | Nîmes | 30029 | France |
|
| Institut Curie | Not yet recruiting | Paris | 75005 | France |
|
| AP HP Groupe Hospitalier Pitié Salpétrière | Not yet recruiting | Paris | 75651 | France |
|
| Institut du Cancer COURLANCY | Not yet recruiting | Reims | 51100 | France |
|
| Centre Eugene Marquis | Not yet recruiting | Rennes | 35000 | France |
|
| Centre Paul Strauss | Not yet recruiting | Strasbourg | 67065 | France |
|
| Chu de Toulouse | Not yet recruiting | Toulouse | 31059 | France |
|
| Institut Gustave Roussy | Not yet recruiting | Villejuif | 94805 | France |
|
| ID | Term |
|---|---|
| D008527 | Medulloblastoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
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