Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) (NCT00626990) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
United States, Australia, Belgium751 participantsStarted 2007-12
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.
PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic 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 diagnosis of 1 of the following:
* Anaplastic oligodendroglioma
* Anaplastic oligoastrocytoma
* Anaplastic astrocytoma
* Newly diagnosed disease
* Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
* Absence of combined 1p/19q loss
* Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review
* Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9 cells/L
* Platelet count ≥ 100 x 10\^9 cells/L
* Bilirubin \< 1.5 x upper limit of normal (ULN)
* Alkaline phosphatase \< 2.5 x ULN
* Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 2.5 x ULN
* Serum creatinine \< 1.5 x ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No known HIV infection or chronic hepatitis B or hepatitis C infection
* No other serious medical condition that would interfere with follow-up
* No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
* No other prior malignancies except for any malignancy which was treated with curative…
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
1
Overall Survival as Measured From the Day of Randomization
Timeframe: from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
Trial details
NCT IDNCT00626990
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC