Radiation Therapy in Treating Young Patients With Gliomas

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
First received: October 12, 2005
Last updated: March 25, 2016
Last verified: March 2016

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.

Condition Intervention Phase
Brain Tumor
Central Nervous System Tumor
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Marginal-failure rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Time from study entry to tumor progression or recurrence, with non-tumor-related deaths or events censored ] [ Designated as safety issue: No ]
    The log rank statistic for comparing life table outcome among subset of patients will be used based on the following prognostic factors: age (3-10 years vs. 11-21 years), prior treatment factors (1 prior chemotherapy, more than 1 prior chemotherapy, and surgery only), location (optic system/hypothalamic vs. hemispheric) and histology (juvenile pilocytic astrocytoma vs. other astrocytoma histologies). Regression model procedures will also be employed to examine issues regarding prognostic factors in this study population.

  • Event-free survival [ Time Frame: Minimum time from study entry to tumor disease progression or recurrence, the occurrence of the second malignant neoplasm, or death from any cause ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Time from study entry to death from any cause ] [ Designated as safety issue: No ]
  • Quality of life (QOL) of these patients (closed as of 10/27/2010). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    QOL assessed using the the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), and the Behavior Rating Inventory of Executive Function (BRIEF). and the Symptom Checklist-90-R (SCL-90-R).

  • MIB-1 Labeling Index using immunohistochemical techniques with the MIB-1 antibody according to established methods [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    The MIB-1 Labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.

  • Correlation MIB-1 Labeling Index with PFS [ Time Frame: From baseline to up to 3 years ] [ Designated as safety issue: No ]
    The primary methods of analysis will be via stratified Cox regression analysis.

Enrollment: 92
Study Start Date: November 2006
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Radiation: radiation therapy
Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Other Names:
  • 3-dimensional conformal radiation therapy
  • intensity-modulated radiation therapy
  • 3D conformal radiation therapy
  • 3D-CRT
  • IMRT

Detailed Description:



  • Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.


  • Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen.
  • Determine quality of life of patients treated with this regimen.
  • Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010).

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.


Ages Eligible for Study:   3 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 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


  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Hemoglobin ≥ 10.0 g/dL (transfusions allowed)


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • 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


  • No prior radiotherapy


  • See Disease Characteristics


  • No other concurrent anticancer therapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00238264

  Show 145 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Joel M. Cherlow, MD Todd Cancer Institute at Long Beach Memorial Medical Center
Study Chair: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00238264     History of Changes
Other Study ID Numbers: ACNS0221  COG-ACNS0221  CIRB-05016  CDR0000445095 
Study First Received: October 12, 2005
Last Updated: March 25, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
childhood oligodendroglioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
childhood low-grade cerebral astrocytoma
recurrent childhood visual pathway and hypothalamic glioma
untreated childhood cerebellar astrocytoma
untreated childhood visual pathway and hypothalamic glioma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on May 26, 2016