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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Medulloblastoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

survival without disease at 1 year

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Luc TAILLANDIER

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU NANCY - France

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2012-002803-16

NCT ID:

NCT01857453

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Medulloblastoma
  • Adult Patients Medulloblatoma Standard risk group Chemotherapy Radiotherapy Quality of Life
  • Medulloblastoma

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