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Spots Global Cancer Trial Database for Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas

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Trial Identification

Brief Title: Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas

Official Title: National, Multicentric, Prospective Phase II Study Estimating the Interest of a Dose Decrease for Radiation Therapy Associated With a Carboplatine and Etoposide Based Chemotherapy for the Treatment of Standard Risk Adult Medulloblastomas

Study ID: NCT01857453

Conditions

Medulloblastoma

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Chu Amiens, Amiens, , France

Chu Bordeaux, Bordeaux, , France

CHU CAEN, Caen, , France

Hopitaux Civils de Colmar, Colmar, , France

Cenre Georges Francois Leclerc, Dijon, , France

Chru de Lille, Lille, , France

Centre Leon Berrard, Lyon, , France

Hopital de La Timone, Marseille, , France

Centre Val D'Aurelle, Montpellier, , France

Chu Nancy, Nancy, , France

Centre René Ganducheau, Nantes, , France

Chu de Nice, Nice, , France

Chu Nimes, Nimes, , France

Institut Curie, Paris, , France

AP HP Groupe Hospitalier Pitié Salpétrière, Paris, , France

Institut du Cancer COURLANCY, Reims, , France

Centre Eugene Marquis, Rennes, , France

Centre Paul Strauss, Strasbourg, , France

Chu de Toulouse, Toulouse, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Luc TAILLANDIER

Affiliation: CHU NANCY - France

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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