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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00002875
Registration number
NCT00002875
Ethics application status
Date submitted
1/11/1999
Date registered
24/05/2004
Date last updated
1/08/2014
Titles & IDs
Public title
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
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Scientific 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
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Secondary ID [1]
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CCG-A9961
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Secondary ID [2]
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A9961
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Tumors
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Central Nervous System Tumors
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Brain
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - filgrastim
Treatment: Drugs - cisplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - lomustine
Treatment: Drugs - mesna
Treatment: Drugs - vincristine sulfate
Treatment: Other - low-LET electron therapy
Treatment: Other - low-LET photon therapy
Experimental: Regimen A - Following surgery, craniospinal irradiation followed by a boost to the primary tumor. Beginning within 1 week after initiation of radiotherapy, patients receive vincristine sulfate weekly for 8 doses. Beginning 6 weeks after the completion of radiotherapy, patients receive adjuvant lomustine/vincristine sulfate/cisplatin every 6 weeks for a total of 8 courses.
Experimental: Regimen B - Following surgery, craniospinal irradiation plus vincristine sulfate, followed by adjuvant cyclophosphamide/vincristine sulfate/cisplatin every 6 weeks for a total of 8 courses.
Other interventions: filgrastim
Treatment: Drugs: cisplatin
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: lomustine
Treatment: Drugs: mesna
Treatment: Drugs: vincristine sulfate
Treatment: Other: low-LET electron therapy
Treatment: Other: low-LET photon therapy
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Intervention code [1]
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Other interventions
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Treatment: Drugs
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
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Event Free Survival
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Assessment method [1]
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Pathologically confirmed posterior fossa medulloblastoma (CCG
diagnosis code 2041) Localized disease required, i.e.: No more than 1.5 square centimeters
of residual tumor on postoperative contrast-enhanced CT or MRI (preferably within 72 hours
but no more than 14 days after surgery) No evidence of metastatic disease on pre- and
postoperative MRI of spine (with dye enhancement) and lumbar cerebrospinal fluid (CSF)
cytology within 3 days prior to surgery Cytologic analysis of ventricular CSF allowed only
if medical contraindication to lumbar puncture and with approval of study chairperson Brain
stem involvement eligible
PATIENT CHARACTERISTICS: Age: 3 to 21 at diagnosis Performance status: Not specified
Hematopoietic: ANC greater than 1,500/mm3 Platelet count greater than 100,000/mm3
Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL ALT less than 1.5
times normal Renal: Nuclear glomerular filtration rate or creatinine clearance greater than
70 mL/min per 1.73 square meters
PRIOR CONCURRENT THERAPY: No prior radiotherapy or chemotherapy (other than
corticosteroids) No more than 31 days since definitive surgery
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Minimum age
3
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Maximum age
22
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/1996
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2011
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Sample size
Target
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Accrual to date
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Final
421
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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California
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Colorado
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District of Columbia
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Illinois
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Indiana
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Nova Scotia
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Puerto Rico
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San Juan
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Switzerland
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Geneva
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Other
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Pediatric Oncology Group
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00002875
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Trial related presentations / publications
Turgut M. Cerebellar mutism. J Neurosurg Pediatr. 2008 Mar;1(3):262. doi: 10.3171/PED/2008/1/3/262.
Robertson PL, Muraszko KM, Holmes EJ, Sposto R, Packer RJ, Gajjar A, Dias MS, Allen JC; Children's Oncology Group. Incidence and severity of postoperative cerebellar mutism syndrome in children with medulloblastoma: a prospective study by the Children's Oncology Group. J Neurosurg. 2006 Dec;105(6 Suppl):444-51. doi: 10.3171/ped.2006.105.6.444.
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Public notes
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Contacts
Principal investigator
Name
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Roger J. Packer, MD
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Address
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Children's National Research Institute
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00002875
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