MedulloblastomaPhase 2RSMA2010NCT01857453
Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas
A Phase 2 study testing carboplatine, Etoposide and radiation therapy in people with Medulloblastoma, run by Central Hospital, Nancy, France at 20 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Medulloblastoma
- What is being tested?
- carboplatine, Etoposide and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 20 sitesFrance
- Study dates
- 10 Apr 2013to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- AID, B and C hepatitis positive serologies
- Negative βHCG dosage and effective contraception for potentially pregnant women
- Writed consent obtain
Who cannot join
- 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
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- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites, 20 recruiting
- Not yet recruiting
Chu Amiens
Amiens, 80053
Mathieu BOONE, Boone.Mathieu@chu-amiens.fr
- Not yet recruiting
Chu Bordeaux
Bordeaux, 33075
Isabelle CATRY THOMAS, isabelle.catry-thomas@chu-bordeaux.fr
- Not yet recruiting
CHU CAEN
Caen, 14000
Jean Sebastien GUILLAMO, guillamo-js@chu-caen.fr
- Not yet recruiting
Hopitaux Civils de Colmar
Colmar, 68024
Jimmy VOIRIN, jimmy.voirin@ch-colmar.fr
- Not yet recruiting
Cenre Georges Francois Leclerc
Dijon, 21079
Veronique LORGIS, vlorgis@cgfl.fr
- Recruiting
Chru de Lille
Lille, 59037
Emilie LE RHUN, emilie.lerhun@chru-lille.fr
- Not yet recruiting
Centre Leon Berrard
Lyon, 69373
Marie Pierre SUNYACH, marie-pierre.sunyach@lyon.unicancer.fr
- Not yet recruiting
Hopital de La Timone
Marseille, 13385
Maryline BARRIE, mbarrie@ap-hm.fr
- Not yet recruiting
Centre Val D'Aurelle
Montpellier, 34298
Christine KERR, Christine.Kerr@icm.unicancer.fr
- Recruiting
Chu Nancy
Nancy, 54000
Luc TAILLANDIER, +33 3 83 85 16 88, l.taillandier@chu-nancy.fr
Charlotte CARNIN, +33 3 83 85 95 92, c.carnin@chu-nancy.fr
- Not yet recruiting
Centre René Ganducheau
Nantes, 44805
Jean Sebastien FRENEL, 02.40.67.97.14
- Not yet recruiting
Chu de Nice
Nice, 06002
Christine LEBRUN FRENAY, lebrun.c@chu-nice.fr
- Not yet recruiting
Chu Nimes
Nîmes, 30029
Chantal CAMPELLO, chantal.campello@chu-nimes.fr
- Not yet recruiting
Institut Curie
Paris, 75005
Claire ALAPETITE, claire.alapetite@curie.net
- Not yet recruiting
AP HP Groupe Hospitalier Pitié Salpétrière
Paris, 75651
Florence LAIGLE DONADEY, florence.laigle-donadey@psl.aphp.fr
- Not yet recruiting
Institut du Cancer COURLANCY
Reims, 51100
Philippe COLIN, pcolin@iccreims.fr
- Not yet recruiting
Centre Eugene Marquis
Rennes, 35000
Elodie VAULEON, E.Vauleon@rennes.unicancer.fr
- Not yet recruiting
Centre Paul Strauss
Strasbourg, 67065
Georges NOEL, GNoel@strasbourg.unicancer.fr
- Not yet recruiting
Chu de Toulouse
Toulouse, 31059
Alexandra BENOUAICH AMIEL, benouaich-amiel.a@chu-toulouse.fr
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94805
Frédéric DHERMAIN, dhermain@igr.fr
About this study
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
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).
Read more
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.
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):
- 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
- 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.
- Conditions
- Medulloblastoma
- Being tested
- carboplatine, Etoposide, radiation therapy
- Keywords
- Adult Patients Medulloblatoma Standard risk group Chemotherapy Radiotherapy Quality of Life
- Medical subject headings
- Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatineDrug
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
EtoposideDrug
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 therapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| teatment arm | Experimental | 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 Receives: Drug: carboplatine; Drug: Etoposide; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival without disease at 1 year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study start10 Apr 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MedulloblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Centre Paul Strauss, Centre Hospitalier Universitaire de Nice, CRLCC Val d'Aurelle, Montpellier, Centre Georges Francois Leclerc, Gustave Roussy, Cancer Campus, Grand Paris, Centre Leon Berard, Groupe Hospitalier Pitie-Salpetriere, Hôpital de la Timone, CHU de Reims, Hopitaux Civils de Colmar, University Hospital, Lille, Institut Claudius Regaud, Centre Francois Baclesse, Center Eugene Marquis, Centre René Gauducheau, Centre Hospitalier Universitaire, Amiens
- Responsible party
- Sponsor
- Investigators
- Luc TAILLANDIER, Principal investigator, CHU NANCY - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857453
- Sponsor's protocol ID
- 2012-002803-16
- Acronym
- RSMA2010
- Status last verified
- Jul 2018
- First submitted
- 16 May 2013
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01857453
- Acronym / sponsor ID
- RSMA2010 / 2012-002803-16
- Conditions
- Medulloblastoma
- Keywords
- Adult Patients Medulloblatoma Standard risk group Chemotherapy Radiotherapy Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Centre Paul Strauss, Centre Hospitalier Universitaire de Nice, CRLCC Val d'Aurelle, Montpellier, Centre Georges Francois Leclerc, Gustave Roussy, Cancer Campus, Grand Paris, Centre Leon Berard, Groupe Hospitalier Pitie-Salpetriere, Hôpital de la Timone, CHU de Reims, Hopitaux Civils de Colmar, University Hospital, Lille, Institut Claudius Regaud, Centre Francois Baclesse, Center Eugene Marquis, Centre René Gauducheau, Centre Hospitalier Universitaire, Amiens
- Study start
- 10 Apr 2013 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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):
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teatment arm | Experimental | Drug: carboplatine, Drug: Etoposide, Radiation: radiation therapycarboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- Age < 18 or > 70 years
- Previous diagnosis of medulloblastoma
- Previous treatment with chemotherapy
- Previous cranial or spinal radiation therapy
- Carboplatinum or etoposide contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatinecarboplatine + 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 | teatment arm |
| Etoposidecarboplatine + 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 | teatment arm |
| radiation therapycarboplatine + 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 | teatment arm |
Primary outcome
survival without disease at 1 year
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc TAILLANDIER principal investigator
CHU NANCY - France
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatine, Etoposide and radiation therapy in people with Medulloblastoma, run by Central Hospital, Nancy, France at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luc TAILLANDIER (+33 3 83 85 16 88, l.taillandier@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival without disease at 1 year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.