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A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas


- Compare the 3-year survival of patients with high-risk low-grade gliomas treated with
temozolomide and radiotherapy followed by temozolomide alone with that of patients
enrolled on European Organization for Research and Treatment of Cancer (EORTC)clinical
trials EORTC-22844 and EORTC-22845.

- Determine the toxicity of this regimen in these patients.

- Determine the association between progression-free survival and O6-methylguanine-DNA
methyltransferase (MGMT) methylation status in patients treated with this regimen.

- Determine the association between survival and MGMT methylation status in patients
treated with this regimen.

- Determine the quality of life (QOL) of patients treated with this regimen.

- Determine the neurocognitive function of patients treated with this regimen.

- Evaluate the feasibility of collecting patient-reported QOL and neurocognitive
assessments over 3 years.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once
daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning 28 days after completion
of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment
with temozolomide repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed periodically for up to 36 months.

After completion of study treatment, patients are followed at 4 months, every 6 months for 2
years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 44 months.

Inclusion Criteria


- Histologically confirmed* supratentorial glioma of 1 of the following histologies:

- Astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic)

- Oligodendroglioma

- Oligoastrocytoma NOTE: *Histologic atypia allowed provided no other histologic
features (i.e., frequent mitoses, endothelial proliferation, and/or acute
necrosis) that would result in a designation of anaplastic astrocytoma,
anaplastic mixed oligodendroglioma or oligoastrocytoma, or glioblastoma
multiforme are present

- Unifocal or multifocal disease

- WHO grade II disease

- Neurofibromatosis allowed

- Surgical biopsy or resection for tumor tissue sampling required within the past 12

- Tissue block or core biopsy available for O6-methylguanine-DNA methyltransferase
analysis and tissue banking

- Patients who have only had a stereotactic biopsy are not eligible

- Must have ≥ 3 of the following risk factors:

- Age 40 and over

- Largest preoperative tumor diameter ≥ 6 cm

- Tumor crosses the midline

- Astrocytoma-dominant tumor subtype

- Preoperative Neurological Function Status > 1

- No other low-grade glioma histologies, including any of the following:

- Pilocytic astrocytoma

- Subependymal giant cell astrocytoma of tuberous sclerosis

- Subependymoma

- Pleomorphic xanthoastrocytoma

- Presence of a neuronal element, such as ganglioglioma

- Dysneuroembryoplastic epithelial tumor

- No high-grade glioma, including any of the following:

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Anaplastic oligodendroglioma

- Anaplastic oligoastrocytoma

- No tumors in any nonsupratentorial location, including any of the following:

- Optic chiasm

- Optic nerve(s)

- Pons

- Medulla

- Cerebellum

- Spinal cord

- No evidence of disease progression to spinal meninges or noncontiguous cranial
meninges (i.e., leptomeningeal gliomatosis) by MRI of the spine or cerebrospinal
fluid (CSF) cytology

- MRI of the spine or CSF cytology are not required for patients without symptoms
of spinal/cranial meningeal disease progression



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Total bilirubin ≤ 1.5 mg/dL

- Serum glutamate oxaloacetate transaminase (SGOT) or Serum glutamate pyruvate
transaminase (SGPT) ≤ 2 times normal

- Alkaline phosphatase ≤ 2 times normal


- Serum creatinine ≤ 1.5 mg/dL


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- No other malignancy within the past 5 years except carcinoma in situ of the cervix or
nonmelanoma skin cancer

- No active infection


Biologic therapy

- No concurrent immunotherapy or biologic therapy


- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy to the head and neck unless head and neck radiotherapy clearly
excluded the brain (e.g., localized radiotherapy to the vocal cords)

- No prior radiotherapy to the brain

- No concurrent intensity modulated radiotherapy

- No concurrent stereotactic boost radiotherapy


- See Disease Characteristics


- No other concurrent investigational agents

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 3 years.

Outcome Time Frame:

Death of last follow-up. Analysis occurs after all patients have been potentially followed for 3 years

Safety Issue:


Principal Investigator

Barbara J. Fisher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

London Regional Cancer Program at London Health Sciences Centre


United States: Federal Government

Study ID:

RTOG 0424



Start Date:

January 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult diffuse astrocytoma
  • adult oligodendroglioma
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
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