Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuva… (NCT00887146) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
United States, Austria, Belgium305 participantsStarted 2009-09
Plain-language summary
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. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.
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.
Pre-Registration Inclusion Criteria:
* United States (US) and Canadian sites:
\* This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible
* Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review
* Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility, the 1p/19q analysis results will be accepted from the local site, as determined by either a locally available or reference laboratory (for US, must be Clinical Laboratory Improvement Act \[CLIA\] certified); acceptable methods for determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by genomic sequencing or methylomic analyses; US and Canadian sites must send a copy of the official report to the pathology coordinator and quality assurance specialist (QAS)
* Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses; this should be performed at the local site (US: performed in a CLIA certified laboratory); the site must send a copy of the official report to the pathology coordinator and QAS
Registration Inclusion Criteria:
* Newly diagnosed and =\< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure \> 3 months earlier for low grade glioma, as long …
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 trial is comparing temozolomide given alongside radiation versus PCV chemotherapy given after radiation — can you help me understand how these two approaches differ in terms of how they're given and what side effects I might expect from each?
2Since this is a Phase 3 trial focused on progression-free survival as the main thing being measured, what do we currently know about how the two treatment arms compare, and is that data mature enough yet to inform my decision?
3The trial is active but no longer enrolling new patients — does that mean the results might be available soon, and should we wait to see those findings before deciding on my treatment plan?
4Given that this study involves anaplastic glioma and low-grade glioma, which category does my specific diagnosis fall into, and does that affect which arm of this trial would have been more relevant for someone like me?
5Are there standard-of-care options for my type of glioma that are already established outside of this trial, and how would those compare to the treatment approaches being studied here?
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
Progression-free survival
Timeframe: Time from study registration to time of tumor progression or death due to any cause, whichever comes first, assessed up to 16 years