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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00238264




Registration number
NCT00238264
Ethics application status
Date submitted
12/10/2005
Date registered
13/10/2005
Date last updated
7/08/2019

Titles & IDs
Public title
Radiation Therapy in Treating Young Patients With Gliomas
Scientific title
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
Secondary ID [1] 0 0
COG-ACNS0221
Secondary ID [2] 0 0
ACNS0221
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
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - radiation therapy

Experimental: Treatment (radiotherapy) - Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.


Treatment: Other: radiation therapy
Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Marginal-failure Rate - Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Progression-free Survival Probability - To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Event-free Survival Probability - To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Overall Survival Probability - To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Quality of Life (QOL) - QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods - The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.
Timepoint [5] 0 0
At baseline
Secondary outcome [6] 0 0
Correlation MIB-1 Labeling Index With PFS - The primary methods of analysis will be via stratified Cox regression
Timepoint [6] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed* low-grade glioma, including any of the following:

- Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA

- Diffuse astrocytoma, including any of the following subtypes:

- Fibrillary astrocytoma

- Gemistocytic astrocytoma

- Subependymal giant cell astrocytoma

- Pleomorphic xanthoastrocytoma

- Low-grade oligoastrocytoma

- Low-grade oligodendroglioma

- Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions
who have contiguous extension of tumor into other regions of the visual pathway
by CT scan or MRI are eligible without histopathologic confirmation; repeat
biopsy required for patients with recurrent tumors that enhance but whose initial
tumor did not

- Measurable disease by radiography

- Meets any of the following criteria:

- Progressive nonresectable disease

- Any location in the brain

- Patients with a less than gross total resection are eligible provided they are
symptomatic from their tumor OR the risk from neurologic impairment with
progression is high enough to warrant immediate treatment

- Has undergone biopsy only

- Must have received = 1 course of prior chemotherapy (for patients < 10 years of age)

- Prior chemotherapy optional (for patients = 10 years of age)

- No type-1 neurofibromatosis

- No evidence of leptomeningeal dissemination

PATIENT CHARACTERISTICS:

Age

- 3 to 20

Performance status

- ECOG 0-2 OR

- Karnofsky 50-100% (for patients > 16 years of age) OR

- Lansky 50-100% (for patients = 16 years of age)

Life expectancy

- At least 1 year

Hematopoietic

- Absolute neutrophil count = 1,000/mm^3

- Platelet count = 100,000/mm^3 (transfusion independent)

- Hemoglobin = 10.0 g/dL (transfusions allowed)

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Not in status epilepticus, coma, or requiring assisted ventilation prior to study
entry

- Patients with a seizure disorder are eligible provided they are on anticonvulsants AND
disease is well controlled

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- Concurrent dexamethasone allowed provided patient has been on a stable dose for = 2
weeks prior to study entry

- Concurrent dexamethasone allowed for symptoms of increased intracranial pressure

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

Other

- No other concurrent anticancer therapy
Minimum age
3 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Completed
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)
QLD,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
6001 - Perth
Recruitment outside Australia
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Alabama
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Arizona
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Delaware
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Geneva
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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 radiation directly to the tumor may
kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating young
patients with gliomas.
Trial website
https://clinicaltrials.gov/show/NCT00238264
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joel M. Cherlow, MD
Address 0 0
Todd Cancer Institute at Long Beach Memorial Medical Center
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
Other publications