Temozolomide and Radiation Therapy in Treating Patients With Gliomas
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Intervention Model: Single Group Assignment 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. [ Time Frame: Death of last follow-up. Analysis occurs after all patients have been potentially followed for 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary analysis. ] [ Designated as safety issue: No ]
- Association of survival and progression-free survival with MGMT methylation status [ Time Frame: from randomization to date of progression, death or last follow-up. Analysis occurs after the primary outcome analysis. ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: From registration to one year. ] [ Designated as safety issue: No ]
- Neurocognitive function [ Time Frame: From registration to one year. ] [ Designated as safety issue: No ]
| Enrollment: | 136 |
| Study Start Date: | January 2005 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Daily temozolomide, radiation therapy, temozolomide
Daily temozolomide plus concurrent radiotherapy (54 Gy/30 fractions/6 weeks) followed by temozolomide x 12 cycles
|
Drug: temozolomide Procedure: adjuvant therapy Radiation: 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 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.
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
- 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00114140
Show 47 Study Locations
| Principal Investigator: | Barbara J. Fisher, MD | London Regional Cancer Program at London Health Sciences Centre | |
| Study Chair: | David R. Macdonald, MD, FRCPC | London Regional Cancer Program at London Health Sciences Centre | |
| Study Chair: | Glenn J. Lesser, MD | Comprehensive Cancer Center of Wake Forest University | |
| Study Chair: | Stephen W. Coons, MD | St. Joseph's Hospital and Medical Center, Phoenix |
More Information
Additional Information:
No publications provided
| Responsible Party: | Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00114140 History of Changes |
| Other Study ID Numbers: | RTOG 0424, CDR0000434849, NCI-2009-00723 |
| Study First Received: | June 13, 2005 |
| Last Updated: | July 10, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by Radiation Therapy Oncology Group:
|
adult diffuse astrocytoma adult oligodendroglioma adult mixed glioma |
Additional relevant MeSH terms:
|
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Temozolomide |
Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015