Clinical Trial: Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
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
- carboplatine + etoposide based chemotherapy every 28 days x 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.
Detailed Summary:
Sponsor: Central Hospital, Nancy, France
Current Primary Outcome: survival without disease at 1 year [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Central Hospital, Nancy, France
Dates:
Date Received: May 16, 2013
Date Started: April 2013
Date Completion:
Last Updated: March 7, 2016
Last Verified: March 2016
