CompletedPhase 2

Temozolomide and Radiation Therapy in Treating Patients With Gliomas

United States, Canada136 participantsStarted 2005-01

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival Rate at 3 Years

Timeframe: Registration to 3 years

Progression-free Survival

Timeframe: From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years.

Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status

Timeframe: Registration to 3 years

Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR)

Timeframe: Baseline, 6 months, and 12 months.

Neurocognitive Function

Timeframe: Baseline, 6 months, and 12 months.

Trial details

NCT IDNCT00114140

SponsorRadiation Therapy Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2013-02

Results submitted2017-01-17

View on ClinicalTrials.gov More Brain and Central Nervous System Tumors trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Overall Survival Rate at 3 Years

Timeframe: Registration to 3 years

Progression-free Survival

Timeframe: From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years.

Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status

Timeframe: Registration to 3 years

Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR)

Timeframe: Baseline, 6 months, and 12 months.

Neurocognitive Function

Timeframe: Baseline, 6 months, and 12 months.