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

July 3, 2018 updated by: Central Hospital, Nancy, France

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).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

97

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival without disease at 1 year
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Centre Leon Berard
CHU de Reims
Centre Hospitalier Universitaire, Amiens
University Hospital, Bordeaux
Centre Hospitalier Universitaire de Nice
Institut Claudius Regaud
University Hospital, Lille
Groupe Hospitalier Pitie-Salpetriere
Gustave Roussy, Cancer Campus, Grand Paris
Center Eugene Marquis
Centre Francois Baclesse
Centre Georges Francois Leclerc
Hôpital de la Timone
Centre René Gauducheau
Hopitaux Civils de Colmar
Centre Paul Strauss
CRLCC Val d'Aurelle, Montpellier

Investigators

  • Principal Investigator: Luc TAILLANDIER, CHU NANCY - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 16, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-002803-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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