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Spots Global Cancer Trial Database for Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

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Trial Identification

Brief Title: Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

Official Title: Phase III Prospective Randomized Study of Craniospinal RT Followed by One of Two Adjuvant Chemotherapy Regimens (CCNU, CDDP, VCR OR CPM, CDDP, VCR) for Newly-Diagnosed Average Risk MedulloblastomaMEDULLOBLASTOMA

Study ID: NCT00002875

Study Description

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. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective when combined with radiation therapy for treating medulloblastoma. PURPOSE: Randomized phase III trial to compare two combination chemotherapy treatments plus radiation therapy in treating children with newly diagnosed medulloblastoma.

Detailed Description: OBJECTIVES: I. Assess whether a cyclophosphamide-containing combination chemotherapy regimen increases progression-free survival compared to a lomustine-containing regimen in children with newly diagnosed, average-risk medulloblastoma. II. Determine progression-free and overall survival of children treated with craniospinal radiotherapy and local boost radiotherapy for a total dose of 5580 cGy followed by adjuvant lomustine/cisplatin/vincristine vs. cyclophosphamide/cisplatin/vincristine. III. Determine the long-term neurocognitive, endocrinologic, and cardiopulmonary sequelae associated with craniospinal radiotherapy, local boost radiotherapy, and adjuvant chemotherapy in these children, and determine whether replacement of lomustine with cyclophosphamide alters the incidence and degree of sequelae. IV. Determine whether cellular and biologic parameters, including tumor molecular genetic analysis, DNA ploidy, mitotic activity markers, and immunohistochemical analysis, are correlated with progression-free survival, overall survival, and patterns of disease relapse in these patients. V. Evaluate the utility of routine magnetic resonance imaging surveillance studies of the head and spine in detecting subclinical recurrent disease. OUTLINE: This is a randomized study. Patients are stratified by participating institution. Following surgery, patients are randomized to one of two groups. The first group receives craniospinal irradiation followed by a boost to the primary tumor. Beginning within 1 week after initiation of radiotherapy, patients receive vincristine weekly for 8 doses. Beginning 6 weeks after the completion of radiotherapy, patients receive adjuvant lomustine/vincristine/cisplatin every 6 weeks for a total of 8 courses. The second group receives craniospinal irradiation plus vincristine as above, followed by adjuvant cyclophosphamide/vincristine/cisplatin every 6 weeks for a total of 8 courses. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually. PROJECTED ACCRUAL: It is anticipated that 240-300 patients will be entered over 4 years.

Eligibility

Minimum Age: 3 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Long Beach Memorial Medical Center, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Children's Hospital of Orange County, Orange, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

Children's Hospital of Denver, Denver, Colorado, United States

Children's National Medical Center, Washington, District of Columbia, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

Children's Mercy Hospital, Kansas City, Missouri, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States

Ireland Cancer Center, Cleveland, Ohio, United States

Children's Hospital of Columbus, Columbus, Ohio, United States

Doernbecher Children's Hospital, Portland, Oregon, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

Vanderbilt Cancer Center, Nashville, Tennessee, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

IWK Grace Health Centre, Halifax, Nova Scotia, Canada

University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico

Clinique de Pediatrie, Geneva, , Switzerland

Contact Details

Name: Roger J. Packer, MD

Affiliation: Children's National Research Institute

Role: STUDY_CHAIR

Name: Amar Gajjar, MD

Affiliation: St. Jude Children's Research Hospital

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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