Radiation Therapy in Treating Young Patients With Gliomas - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238264

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 and Central Nervous System Tumors	Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Marginal-failure rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Event-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2006
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

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

PROJECTED ACCRUAL: A total of 100-150 patients will be accrued for this study over approximately 3-4.5 years.

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

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

Show 136 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Joel M. Cherlow, MD	Todd Cancer Institute at Long Beach Memorial Medical Center
Investigator:	Edward G. Shaw, MD	Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000445095, COG-ACNS0221, CIRB-05016
Study First Received:	October 12, 2005
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00238264 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Nervous System Diseases

Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010