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ClinicalTrials.gov ID

NCT01857453

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

97Estimated

Last Update Posted

Jul 5, 2018Actual

Start Date

Apr 10, 2013Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2021Estimated

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

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.

• Medulloblastoma

• carboplatine
• Etoposide
• radiation therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

University Hospital, BordeauxOTHER

Centre Paul StraussOTHER

Centre Hospitalier Universitaire de NiceOTHER

CRLCC Val d'Aurelle, MontpellierUNKNOWN

Centre Georges Francois LeclercOTHER

Gustave Roussy, Cancer Campus, Grand ParisOTHER

Centre Leon BerardOTHER

Groupe Hospitalier Pitie-SalpetriereOTHER

Hôpital de la TimoneOTHER

CHU de ReimsOTHER

Hopitaux Civils de ColmarOTHER

University Hospital, LilleOTHER

Institut Claudius RegaudOTHER

Centre Francois BaclesseOTHER

Center Eugene MarquisOTHER

Centre René GauducheauOTHER

Centre Hospitalier Universitaire, AmiensOTHER

l.taillandier@chu-nancy.fr+33 3 83 85 16 88