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 States305 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 range18 Years
SexALL
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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 …
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