Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma (NCT00978458) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
United States540 participantsStarted 2009-11-17
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 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. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.
PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.
Who can participate
Age range
18 Years – 120 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 low-grade glioma, including 1 of the following:
* Grade 2 astrocytoma
* Grade 2 oligodendroglioma
* Grade 2 oligoastrocytoma (mixed glioma containing astrocytoma and oligodendroglioma)
* NOTE: \*If the pathology from multiple procedures supports the diagnosis of a brain tumor, the qualifying pathology of grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma must be the most recent pathological diagnosis; no pathological diagnosis of grade 3 or 4 glioma at any time
* Paraffin-embedded tumor specimen available for submission for confirmation of pathological review and determination of 1p and 19q deletion status
* Patients must currently meet ≥ 1 of the following criteria\*:
* Uncontrolled symptoms, defined as any of the following:
* Headaches associated with mass effect
* Uncontrolled seizures despite two different antiepileptic drug regimens (i.e., two antiepileptic drugs tested either sequentially or in combination)
* Focal neurological symptoms
* Cognitive symptoms or deficits
* Tumor progression by serial MRIs, defined as any of the following:
* New or progressive enhancement
* New or progressive T2 or FLAIR signal abnormality
* Age ≥ 40 years
* NOTE: \*Patients \< 40 years of age whose only symptom of low-grade glioma is seizures that are well-controlled on antiepileptic drugs AND who have no evidence of radiographic progression are not eligible.
* Patients w…
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.
1This is a Phase 3 trial comparing radiation therapy alone versus radiation with temozolomide for low-grade glioma — does my specific tumor type, grade, and genetic profile make me a good candidate to discuss this trial with my care team?
2Since one of the things this trial is specifically measuring is neurotoxicity, what are the known or potential cognitive and neurological side effects I should weigh when comparing radiation alone to radiation plus temozolomide?
3The trial is active but no longer enrolling new patients — does that mean results or interim data are available that my doctor could use to inform my treatment plan, even if I can't join the study?
4How does adding temozolomide to radiation compare to standard of care options for low-grade glioma right now, and would my doctor recommend I start standard treatment first rather than waiting to see if trial data changes the approach?
5Given that this trial is measuring both progression-free survival and overall survival as its main outcomes, how long would I likely need to be monitored, and what does that kind of long-term follow-up mean for my life and schedule?
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.