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Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas (RSMA2010)

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ClinicalTrials.gov Identifier: NCT01857453
Recruitment Status : Recruiting
First Posted : May 20, 2013
Last Update Posted : July 4, 2018
Sponsor:
Collaborators:
University Hospital, Bordeaux
Centre Paul Strauss
Centre Hospitalier Universitaire de Nice
CRLCC Val d'Aurelle, Montpellier
Centre Georges Francois Leclerc
Institut Gustave Roussy, VILLEJUIF
Centre Leon Berard
Groupe Hospitalier Pitie-Salpetriere
Hôpital de la Timone
CHU de Reims
Hôpitaux Civils de Colmar
University Hospital, Lille
Institut Claudius Regaud
Centre Francois Baclesse
Center Eugene Marquis
Centre René Gauducheau
Centre Hospitalier Universitaire, Amiens
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment Phase
Medulloblastoma Drug: carboplatine Drug: Etoposide Radiation: radiation therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 10, 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: teatment arm
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
Drug: carboplatine
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

Drug: Etoposide
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

Radiation: radiation 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




Primary Outcome Measures :
  1. survival without disease at 1 year [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857453


Contacts
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Contact: Luc TAILLANDIER +33 3 83 85 16 88 l.taillandier@chu-nancy.fr
Contact: Charlotte CARNIN +33 3 83 85 95 92 c.carnin@chu-nancy.fr

Locations
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France
Chu Amiens Not yet recruiting
Amiens, France, 80053
Contact: Mathieu BOONE       Boone.Mathieu@chu-amiens.fr   
Chu Bordeaux Not yet recruiting
Bordeaux, France, 33075
Contact: Isabelle CATRY THOMAS       isabelle.catry-thomas@chu-bordeaux.fr   
CHU CAEN Not yet recruiting
Caen, France, 14000
Contact: Jean Sebastien GUILLAMO       guillamo-js@chu-caen.fr   
Hopitaux Civils de Colmar Not yet recruiting
Colmar, France, 68024
Contact: Jimmy VOIRIN       jimmy.voirin@ch-colmar.fr   
Cenre Georges Francois Leclerc Not yet recruiting
Dijon, France, 21079
Contact: Veronique LORGIS       vlorgis@cgfl.fr   
Chru de Lille Recruiting
Lille, France, 59037
Contact: Emilie LE RHUN       emilie.lerhun@chru-lille.fr   
Centre Leon Berrard Not yet recruiting
Lyon, France, 69373
Contact: Marie Pierre SUNYACH       marie-pierre.sunyach@lyon.unicancer.fr   
Hopital de La Timone Not yet recruiting
Marseille, France, 13385
Contact: Maryline BARRIE       mbarrie@ap-hm.fr   
Centre Val D'Aurelle Not yet recruiting
Montpellier, France, 34298
Contact: Christine KERR       Christine.Kerr@icm.unicancer.fr   
Chu Nancy Recruiting
Nancy, France, 54000
Contact: Luc TAILLANDIER    +33 3 83 85 16 88    l.taillandier@chu-nancy.fr   
Contact: Charlotte CARNIN    +33 3 83 85 95 92    c.carnin@chu-nancy.fr   
Centre René Ganducheau Not yet recruiting
Nantes, France, 44805
Contact: Jean Sebastien FRENEL    02.40.67.97.14      
Chu de Nice Not yet recruiting
Nice, France, 06002
Contact: Christine LEBRUN FRENAY       lebrun.c@chu-nice.fr   
Chu Nimes Not yet recruiting
Nimes, France, 30029
Contact: Chantal CAMPELLO       chantal.campello@chu-nimes.fr   
Institut Curie Not yet recruiting
Paris, France, 75005
Contact: Claire ALAPETITE       claire.alapetite@curie.net   
AP HP Groupe Hospitalier Pitié Salpétrière Not yet recruiting
Paris, France, 75651
Contact: Florence LAIGLE DONADEY       florence.laigle-donadey@psl.aphp.fr   
Institut du Cancer COURLANCY Not yet recruiting
Reims, France, 51100
Contact: Philippe COLIN       pcolin@iccreims.fr   
Centre Eugene Marquis Not yet recruiting
Rennes, France, 35000
Contact: Elodie VAULEON       E.Vauleon@rennes.unicancer.fr   
Centre Paul Strauss Not yet recruiting
Strasbourg, France, 67065
Contact: Georges NOEL       GNoel@strasbourg.unicancer.fr   
Chu de Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Alexandra BENOUAICH AMIEL       benouaich-amiel.a@chu-toulouse.fr   
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Frédéric DHERMAIN       dhermain@igr.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
University Hospital, Bordeaux
Centre Paul Strauss
Centre Hospitalier Universitaire de Nice
CRLCC Val d'Aurelle, Montpellier
Centre Georges Francois Leclerc
Institut Gustave Roussy, VILLEJUIF
Centre Leon Berard
Groupe Hospitalier Pitie-Salpetriere
Hôpital de la Timone
CHU de Reims
Hôpitaux Civils de Colmar
University Hospital, Lille
Institut Claudius Regaud
Centre Francois Baclesse
Center Eugene Marquis
Centre René Gauducheau
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Luc TAILLANDIER CHU NANCY - France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01857453     History of Changes
Other Study ID Numbers: 2012-002803-16
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

Keywords provided by Central Hospital, Nancy, France:
Adult Patients Medulloblatoma Standard risk group Chemotherapy Radiotherapy Quality of Life

Additional relevant MeSH terms:
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Medulloblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action