Temozolomide and Radiation Therapy in Treating Patients With Gliomas
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Purpose
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 uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with low-grade gliomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas |
- Overall survival at 3 years [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity rate [ Designated as safety issue: Yes ]
- Association of survival and progression-free survival with MGMT methylation status [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Neurocognitive function [ Designated as safety issue: No ]
| Estimated Enrollment: | 135 |
| Study Start Date: | January 2005 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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 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
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
- SGOT or 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
Contacts and Locations
Show 47 Study Locations| Study Chair: | Barbara J. Fisher, MD | London Regional Cancer Program at London Health Sciences Centre |
| Investigator: | David R. Macdonald, MD, FRCPC | London Regional Cancer Program at London Health Sciences Centre |
| Investigator: | Glenn J. Lesser, MD | Comprehensive Cancer Center of Wake Forest University |
| Investigator: | Stephen W. Coons, MD | St. Joseph's Hospital and Medical Center, Phoenix |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00114140 History of Changes |
| Other Study ID Numbers: | CDR0000434849, RTOG-0424 |
| Study First Received: | June 13, 2005 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult diffuse astrocytoma adult oligodendroglioma adult mixed glioma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013