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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00027846
Registration number
NCT00027846
Ethics application status
Date submitted
7/12/2001
Date registered
27/01/2003
Date last updated
7/08/2019
Titles & IDs
Public title
Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
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Scientific title
A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma
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Secondary ID [1]
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CDR0000069086
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Secondary ID [2]
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ACNS0121
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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 Tumor
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Central Nervous System Tumor
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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Cancer
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Neuroendocrine tumour (NET)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - filgrastim
Treatment: Drugs - carboplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy
Treatment: Drugs - Mesna
No intervention: GTR1 Differentiated Histology Supratentorial (Group 1) - Patients undergo observation.
Experimental: Radiation (Group 2) - Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
Experimental: Sub-Total Resection Any Histology or Location (STR) (Group 3) - Patients receive an initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
Treatment: Other: filgrastim
Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/µl given subcutaneously or intravenously.
Treatment: Drugs: carboplatin
Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA \<0.45m2 the dose is 12.5 mg/kg/day.
Treatment: Drugs: cyclophosphamide
Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA\<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.
Treatment: Drugs: etoposide
Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA \< 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.
Treatment: Drugs: vincristine sulfate
Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA\<0.45m2 the dose is 0.05mg/kg.
Treatment: Other: radiation therapy
Given once daily 5 days a week for 6-6½ weeks
Treatment: Drugs: Mesna
Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA\<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival
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Assessment method [1]
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Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.
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Timepoint [1]
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Up to 5 years after completion of study treatment
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.
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Timepoint [1]
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Up to 5 years after completion of study treatment
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Secondary outcome [2]
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Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy
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Assessment method [2]
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The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.
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Timepoint [2]
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At the time of second surgery
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Secondary outcome [3]
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Event-free Survival (EFS)
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Assessment method [3]
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EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.
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Timepoint [3]
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At 5 years since the time of radiation therapy.
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Secondary outcome [4]
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Event-free Survival (EFS)
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Assessment method [4]
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EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.
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Timepoint [4]
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At 5 years since the time of radiation therapy
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Secondary outcome [5]
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Local Control and Patterns of Failure
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Assessment method [5]
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Documented and analyzed qualitatively and quantitatively.
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Timepoint [5]
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Up to 5 years after completion of study treatment
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed intracranial ependymoma
* Differentiated ependymoma or anaplastic ependymoma
* No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
* No evidence of noncontiguous spread beyond primary site
* Initial surgical resection within the past 56 days
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* No restrictions
Life expectancy:
* At least 2 months
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Able to undergo MRI
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior or concurrent corticosteroids allowed
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
* More than 1 prior surgery allowed
Other:
* No other prior treatment for ependymoma
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Minimum age
1
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Maximum age
21
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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
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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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
1/08/2003
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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
31/03/2016
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Sample size
Target
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Accrual to date
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Final
378
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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John Hunter Hospital - Newcastle
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Prince of Wales Private Hospital - Randwick
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Royal Children's Hospital - Herston, Brisbane
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Women's and Children's Hospital - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2310 - Newcastle
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2031 - Randwick
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2145 - Westmead
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4029 - Herston, Brisbane
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5006 - North Adelaide
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3052 - Parkville
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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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Alabama
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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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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.
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Trial website
https://clinicaltrials.gov/study/NCT00027846
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thomas E. Merchant, DO, PhD
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Address
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St. Jude Children's Research Hospital
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00027846
Download to PDF