Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas
RSMA2010
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
1 other identifier
interventional
97
1 country
20
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
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2013
Longer than P75 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2013
CompletedFirst Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 5, 2018
July 1, 2018
5.6 years
May 16, 2013
July 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
survival without disease at 1 year
one year
Study Arms (1)
teatment arm
EXPERIMENTALcarboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 or \> 70 years
- Previous diagnosis of medulloblastoma
- Previous treatment with chemotherapy
- Previous cranial or spinal radiation therapy
- Carboplatinum or etoposide contraindication
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Hospital, Nancy, Francelead
- University Hospital, Bordeauxcollaborator
- Centre Paul Strausscollaborator
- Centre Hospitalier Universitaire de Nicecollaborator
- CRLCC Val d'Aurelle, Montpelliercollaborator
- Centre Georges Francois Leclerccollaborator
- Gustave Roussy, Cancer Campus, Grand Pariscollaborator
- Centre Leon Berardcollaborator
- Groupe Hospitalier Pitie-Salpetrierecollaborator
- Hôpital de la Timonecollaborator
- CHU de Reimscollaborator
- Hopitaux Civils de Colmarcollaborator
- University Hospital, Lillecollaborator
- Institut Claudius Regaudcollaborator
- Centre Francois Baclessecollaborator
- Center Eugene Marquiscollaborator
- Centre René Gauducheaucollaborator
- Centre Hospitalier Universitaire, Amienscollaborator
Study Sites (20)
Chu Amiens
Amiens, 80053, France
Chu Bordeaux
Bordeaux, 33075, France
CHU CAEN
Caen, 14000, France
Hopitaux Civils de Colmar
Colmar, 68024, France
Cenre Georges Francois Leclerc
Dijon, 21079, France
Chru de Lille
Lille, 59037, France
Centre Leon Berrard
Lyon, 69373, France
Hopital de La Timone
Marseille, 13385, France
Centre Val D'Aurelle
Montpellier, 34298, France
Chu Nancy
Nancy, 54000, France
Centre René Ganducheau
Nantes, 44805, France
Chu de Nice
Nice, 06002, France
Chu Nimes
Nîmes, 30029, France
Institut Curie
Paris, 75005, France
AP HP Groupe Hospitalier Pitié Salpétrière
Paris, 75651, France
Institut du Cancer COURLANCY
Reims, 51100, France
Centre Eugene Marquis
Rennes, 35000, France
Centre Paul Strauss
Strasbourg, 67065, France
Chu de Toulouse
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc TAILLANDIER
CHU NANCY - France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 20, 2013
Study Start
April 10, 2013
Primary Completion
December 1, 2018
Study Completion
December 1, 2021
Last Updated
July 5, 2018
Record last verified: 2018-07