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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00027846




Registration number
NCT00027846
Ethics application status
Date submitted
7/12/2001
Date registered
27/01/2003
Date last updated
1/03/2017

Titles & IDs
Public title
Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
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
Secondary ID [1] 0 0
CDR0000069086
Secondary ID [2] 0 0
ACNS0121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumor 0 0
Central Nervous System Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim
Treatment: Drugs - carboplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy
Treatment: Drugs - Mesna
Treatment: Surgery - therapeutic conventional surgery

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.


Other interventions: 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.

Treatment: Surgery: therapeutic conventional surgery


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
Intervention code [4] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free Survival - 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.
Timepoint [1] 0 0
Up to 5 years after completion of study treatment
Secondary outcome [1] 0 0
Overall Survival - 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.
Timepoint [1] 0 0
Up to 5 years after completion of study treatment
Secondary outcome [2] 0 0
Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy - The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.
Timepoint [2] 0 0
At the time of second surgery
Secondary outcome [3] 0 0
Event-free Survival (EFS) - 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.
Timepoint [3] 0 0
At 5 years since the time of radiation therapy.
Secondary outcome [4] 0 0
Event-free Survival (EFS) - 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.
Timepoint [4] 0 0
At 5 years since the time of radiation therapy
Secondary outcome [5] 0 0
Local Control and Patterns of Failure - Documented and analyzed qualitatively and quantitatively.
Timepoint [5] 0 0
Up to 5 years after completion of study treatment

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
Minimum age
1 Year
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Children's Hospital - Herston, Brisbane
Recruitment hospital [5] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Newcastle
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston, Brisbane
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
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Arizona
Country [3] 0 0
United States of America
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Arkansas
Country [4] 0 0
United States of America
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California
Country [5] 0 0
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Colorado
Country [6] 0 0
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Connecticut
Country [7] 0 0
United States of America
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Delaware
Country [8] 0 0
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District of Columbia
Country [9] 0 0
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Quebec
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Canada
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Saskatchewan
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Netherlands
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Groningen
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New Zealand
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Auckland
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Switzerland
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Bern
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Switzerland
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Geneva
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Switzerland
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Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00027846
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas E. Merchant, DO, PhD
Address 0 0
St. Jude Children's Research Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00027846