Radiation Therapy in Treating Young Patients With Gliomas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00238264
First received: October 12, 2005
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   3 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238264

  Show 145 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
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

Additional Information:
Publications:
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: February 26, 2014
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:
Brain Neoplasms
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 20, 2014