Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

NCT00053872 | Unknown Phase 3

• 4 other identifiers: CDR0000269521SIOP-PNET-4EU-20244UKCCSG-CNS-2003-05
• Study Type: interventional
• Target: 316
• Locations: 8 countries
• Sites: 8

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood medulloblastoma

Outcome Measures

Primary Outcomes (1)

• Comparison of event-free survival at 3 years

Secondary Outcomes (4)

• Comparison of overall survival

• Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed])

• Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies

• Toxicity of neurosurgery

Interventions

cisplatin DRUG

lomustine DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (8)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Institut Curie Hopital

Paris, 75248, France

Location

Universitaets - Kinderklinik Wuerzburg

Würzburg, D-97080, Germany

Location

Ospedale Infantile Regina Margherita

Turin, 10126, Italy

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Hospital de Cruces

Vizcaya, 48, Spain

Location

Ostra Sjukhuset

Gothenburg, 41685, Sweden

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Cisplatin; Lomustine; Vincristine; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Brigitta Lannering, MD, PhD

  Ostra Sjukhuset

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: February 1, 2003
• Last Updated: June 24, 2014

Record last verified: 2007-02

Locations

BE (1); IT (1); GB (1); ES (1); NL (1); DE (1); SE (1); FR (1)