Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053872
First received: February 5, 2003
Last updated: June 23, 2014
Last verified: February 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of event-free survival at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of overall survival [ Designated as safety issue: No ]
  • Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed]) [ Designated as safety issue: No ]
  • Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies [ Designated as safety issue: No ]
  • Toxicity of neurosurgery [ Designated as safety issue: Yes ]

Estimated Enrollment: 316
Study Start Date: February 2003
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 3 to 21

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Hematological function less than CTC grade 2

Hepatic

  • Liver function less than CTC grade 2

Renal

  • Renal function less than CTC grade 2

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

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

Radiotherapy

  • No concurrent cobalt irradiation

Surgery

  • See Disease Characteristics

Other

  • No prior treatment for brain tumor or any other malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053872

Locations
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
Institut Curie Hopital
Paris, France, 75248
Germany
Universitaets - Kinderklinik Wuerzburg
Wuerzburg, Germany, D-97080
Italy
Ospedale Infantile Regina Margherita
Turin, Italy, 10126
Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Spain
Hospital de Cruces
Vizcaya, Spain, 48
Sweden
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
Investigators
Study Chair: Brigitta Lannering, MD, PhD Ostra Sjukhuset
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00053872     History of Changes
Other Study ID Numbers: CDR0000269521, SIOP-PNET-4, EU-20244, UKCCSG-CNS-2003-05
Study First Received: February 5, 2003
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 22, 2014