Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053872
Recruitment Status : Unknown
Verified February 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2003
Last Update Posted : June 24, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery. It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: cisplatin Drug: lomustine Drug: vincristine sulfate Procedure: adjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the event-free survival rate in pediatric patients with standard-risk medulloblastoma treated with conventional vs hyperfractionated radiotherapy and vincristine followed by maintenance with cisplatin, lomustine, and vincristine.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the pattern of relapse, especially local relapse (tumor bed or posterior fossa outside tumor bed), in patients treated with these regimens.
  • Determine the toxicity of surgery and whether there are identifiable factors that correlate with toxicity in these patients.
  • Determine the impact of any surgical complications on commencement of adjuvant therapy and event-free survival of these patients.
  • Compare late sequelae, in terms of health status, endocrine deficiencies, and hearing loss, in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to country. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Within 28-40 days after surgical resection, patients undergo conventional fractionated radiotherapy once daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine IV once weekly for 8 weeks.
  • Arm II: Beginning as in arm I, patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine as in arm I.
  • Maintenance chemotherapy:Six weeks after completion of radiotherapy, all patients receive cisplatin IV over 6 hours and oral lomustine on day 1 and vincristine IV on days 1, 8, and 15. Treatment repeats every 6 weeks for 8 courses.

Patients are followed at least every 6 months for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 316 patients (158 per treatment arm) will be accrued for this study within 4 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma
Study Start Date : February 2003

Primary Outcome Measures :
  1. Comparison of event-free survival at 3 years

Secondary Outcome Measures :
  1. Comparison of overall survival
  2. Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed])
  3. Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies
  4. Toxicity of neurosurgery

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed medulloblastoma, including the following variants:

    • Classic
    • Nodular/desmoplastic
    • Large cell
    • Melanotic
    • Medullomyoblastoma
  • Prior total or subtotal surgical removal of tumor within the past 28-40 days

    • No more than 1.5 cm^2 residual tumor by early postoperative MRI or CT scan
  • No brainstem or supratentorial primitive neuroectodermal tumor
  • No atypical teratoid rhabdoid tumor
  • No known predisposition to medulloblastoma (e.g., Gorlin's syndrome)
  • No CNS metastasis (supratentorial, arachnoid of the posterior fossa, or craniospinal axis) by MRI
  • No clinical evidence of metastasis outside the CNS
  • No tumor cells in lumbar cerebrospinal fluid by cytospin



  • 3 to 21

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Hematological function less than CTC grade 2


  • Liver function less than CTC grade 2


  • Renal function less than CTC grade 2


  • Not pregnant
  • Fertile patients must use effective contraception
  • Able to receive radiotherapy twice daily
  • Vital functions within age-appropriate normal range
  • Audiological function less than CTC grade 2
  • No medical contraindication to radiotherapy or chemotherapy


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Concurrent dexamethasone as an antiemetic allowed, provided all other therapies have failed


  • No concurrent cobalt irradiation


  • See Disease Characteristics


  • No prior treatment for brain tumor or any other malignancy

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 identifier (NCT number): NCT00053872

U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Institut Curie Hopital
Paris, France, 75248
Universitaets - Kinderklinik Wuerzburg
Wuerzburg, Germany, D-97080
Ospedale Infantile Regina Margherita
Turin, Italy, 10126
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Hospital de Cruces
Vizcaya, Spain, 48
Ostra Sjukhuset
Gothenburg, Sweden, 41685
United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Sponsors and Collaborators
University of Leicester
Study Chair: Brigitta Lannering, MD, PhD Ostra Sjukhuset Identifier: NCT00053872     History of Changes
Other Study ID Numbers: CDR0000269521
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: February 2007

Keywords provided by National Cancer Institute (NCI):
untreated childhood medulloblastoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents