Status:
UNKNOWN
Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas
Lead Sponsor:
Central Hospital, Nancy, France
Collaborating Sponsors:
University Hospital, Bordeaux
Centre Paul Strauss
Conditions:
Medulloblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 metastasi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01857453
Start Date
April 10 2013
End Date
December 1 2021
Last Update
July 5 2018
Active Locations (20)
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1
Chu Amiens
Amiens, France, 80053
2
Chu Bordeaux
Bordeaux, France, 33075
3
CHU CAEN
Caen, France, 14000
4
Hopitaux Civils de Colmar
Colmar, France, 68024