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Radiation Therapy in Treating Young Patients With Gliomas

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ClinicalTrials.gov Identifier: NCT00238264
Recruitment Status : Completed
First Posted : October 13, 2005
Results First Posted : February 23, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE October 12, 2005
First Posted Date  ICMJE October 13, 2005
Results First Submitted Date  ICMJE January 5, 2017
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date August 7, 2019
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 30, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
Marginal-failure Rate [ Time Frame: Up to 5 years ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • Progression-free Survival Probability [ Time Frame: 3 years ]
    To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
  • Event-free Survival Probability [ Time Frame: 3 years ]
    To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation
  • Overall Survival Probability [ Time Frame: 3 years ]
    To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
  • Quality of Life (QOL) [ Time Frame: Up to 5 years ]
    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).
  • MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods [ Time Frame: At baseline ]
    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: Up to 10 years ]
    The primary methods of analysis will be via stratified Cox regression
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy in Treating Young Patients With Gliomas
Official Title  ICMJE A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Tumor
  • Central Nervous System Tumor
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Radiation: radiation therapy
Publications * Ulin K, Urie MM, Cherlow JM. Results of a multi-institutional benchmark test for cranial CT/MR image registration. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1584-9. doi: 10.1016/j.ijrobp.2009.10.017. Epub 2010 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2014)
92
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00238264
Other Study ID Numbers  ICMJE ACNS0221
COG-ACNS0221 ( Other Identifier: Clinical Trials.gov )
CIRB-05016 ( Other Identifier: Pediatric CIRB )
CDR0000445095 ( Other Identifier: Clinical Trials.gov )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Joel M. Cherlow, MD Todd Cancer Institute at Long Beach Memorial Medical Center
Study Chair: Edward G. Shaw, MD Wake Forest University Health Sciences
PRS Account Children's Oncology Group
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP