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A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas

Phase 2
3 Years
20 Years
Open (Enrolling)
Brain Tumor, Central Nervous System Tumor

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Trial Information

A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas



- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Marginal-failure rate

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Joel M. Cherlow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Todd Cancer Institute at Long Beach Memorial Medical Center


United States: Federal Government

Study ID:




Start Date:

November 2006

Completion Date:

Related Keywords:

  • Brain Tumor
  • Central Nervous System Tumor
  • 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
  • Brain Neoplasms
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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Children's Hospital Central California Madera, California  93638-8762
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Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee, Wisconsin  53226
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
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Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
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Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
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Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
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Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
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Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Childrens Hospital Los Angeles Los Angeles, California  90027
Children's Hospital and Research Center Oakland Oakland, California  94609
Rady Children's Hospital - San Diego San Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Children's Hospital Center for Cancer and Blood Disorders Aurora, Colorado  80045
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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
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Simmons Cooper Cancer Institute Springfield, Illinois  62794-9677
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Maimonides Cancer Center at Maimonides Medical Center Brooklyn, New York  11219
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
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Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
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