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Status:

COMPLETED

Temozolomide and Radiation Therapy in Treating Patients With Gliomas

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

NRG Oncology

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy ...

Detailed Description

OBJECTIVES: * 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 Euro...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • World Health Organization (WHO) grade II disease
  • Neurofibromatosis allowed
  • Surgical biopsy or resection for tumor tissue sampling required within the past 12 weeks
  • 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 non-supratentorial 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • 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
  • Renal
  • Serum creatinine ≤ 1.5 mg/dL
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent immunotherapy or biologic therapy
  • Chemotherapy
  • No prior chemotherapy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • 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
  • Surgery
  • See Disease Characteristics
  • Other
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 20 2022

    Estimated Enrollment :

    136 Patients enrolled

    Trial Details

    Trial ID

    NCT00114140

    Start Date

    January 1 2005

    End Date

    May 20 2022

    Last Update

    July 8 2024

    Active Locations (47)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (47 locations)

    1

    Arizona Oncology Services Foundation

    Phoenix, Arizona, United States, 85013

    2

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    3

    CCOP - Christiana Care Health Services

    Newark, Delaware, United States, 19713

    4

    University of Florida Shands Cancer Center

    Gainesville, Florida, United States, 32610-0232