Medulloblastoma
Conditions
Keywords
Adult Patients Medulloblatoma Standard risk group Chemotherapy Radiotherapy Quality of Life
Brief summary
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 1. carboplatine + etoposide based chemotherapy every 28 days x 2 2. followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed. 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): 1. 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 2. A radiological study is planed with the aim to estimate the interest : * of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature detection of recurrences * of the study of functional connectivity in correlation with the neuropsychological follow-up for the analysis of the aetiology and premature markers of neurotoxicity.
Interventions
DRUGcarboplatine
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
DRUGEtoposide
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
RADIATIONradiation therapy
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
Sponsors
University Hospital, Bordeaux
Centre Paul Strauss
Centre Hospitalier Universitaire de Nice
CRLCC Val d'Aurelle, Montpellier
Centre Georges Francois Leclerc
Gustave Roussy, Cancer Campus, Grand Paris
Centre Leon Berard
Groupe Hospitalier Pitie-Salpetriere
Hôpital de la Timone
CHU de Reims
Hopitaux Civils de Colmar
University Hospital, Lille
Institut Claudius Regaud
Centre Francois Baclesse
Center Eugene Marquis
Centre René Gauducheau
Centre Hospitalier Universitaire, Amiens
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pathologic diagnosis of medulloblastoma expect large cells type * Patients between 18 and 70 years * Résidual tumor les than 1.5 square centimeter (greater diameter) * No sus tentorial or spinal location * Absence of tumoral cells in the cerebrospinal fluid taken before, during or 14 days after surgery * Absence of MYC amplification * AID, B and C hepatitis positive serologies * Negative βHCG dosage and effective contraception for potentially pregnant women * Writed consent obtain
Exclusion criteria
* Age \< 18 or \> 70 years * Previous diagnosis of medulloblastoma * Previous treatment with chemotherapy * Previous cranial or spinal radiation therapy * Carboplatinum or etoposide contraindication * Previous cancer in the five years before the inclusion except basocellular carcinoma of the skin and in situ cancer of the uterine cervix * Severe renal renal insufficiency with a creatinine clearance \< 60 ml/min * Liver insufficiency with a contraindication of carboplatinum or etoposide based chemotherapy or elevated transaminases \> 3N. * Insufficient haematopoetic reserve (thrombocytes \< 100 000/mm3 ou neutrophil polynuclear \< 1500/mm3) * Previous organ transplantation or immunosuppression * Pregnant women or women without contraception * Incapacity of respecting the recommanded follow up * Participation in another therapeutic clinical trial * Patient under custody * Not social security regime membership
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival without disease at 1 year | one year |
Countries
France
Contacts
Primary ContactLuc TAILLANDIER
Backup ContactCharlotte CARNIN
Outcome results
None listed