Study Summary
This trial is comparing the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in treating newly diagnosed MGMT methylated glioblastoma.
- Glioblastoma
- Gliosarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Up to 4 years
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
Arm I (radiation therapy, temozolomide)
1 of 2
ARM II (radiation therapy, temozolomide, lomustine)
1 of 2
Active Control
Experimental Treatment
306 Total Participants · 2 Treatment Groups
Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 24 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are there certain inclusion criteria for this research study?
"This study is recruiting 306 individuals that have glioblastoma and are between 18-70 years old." - Anonymous Online Contributor
How many volunteers are participating in this experiment?
"In order to run this clinical trial, 306 patients that meet the given inclusion criteria are needed. These individuals can participate at one of many different sites including Fairview Southdale Hospital or Aurora Saint Luke's Medical Center." - Anonymous Online Contributor
How does this Quality-of-Life Assessment compare to others in its field?
"The Quality-of-Life Assessment was first trialed in 2002 at Memorial Sloan Kettering Cancer Center. In the 18 years since, there have been 542 completed studies on this topic. There are currently 234 live trials, many of which based out of Edina, Minnesota." - Anonymous Online Contributor
Does this trial seek octogenarian participants?
"This trial's age requirements for participation are between 18 and 70 years old." - Anonymous Online Contributor
Is Quality-of-Life Assessment a risk-free way to improve patient care?
"There is prior clinical data supporting Quality-of-Life Assessment's safety, so it received a score of 3." - Anonymous Online Contributor
Is this a unique clinical trial?
"There have been a total of 234 ongoing trials for Quality-of-Life Assessment spread out over 969 cities and 39 countries. The first such trial was sponsored by Schering-Plough in 2002. That study completed its Phase 2 drug approval stage with 60 patients. In the almost two decades since that initial study, 542 similar trials have been completed." - Anonymous Online Contributor
What issues does Quality-of-Life Assessment commonly address?
"Quality-of-Life Assessments are commonly used to establish patient directives in advance of treatment. However, they can also be useful for tracking the progression of hodgkin disease and measuring the efficacy of nitrosourea treatments." - Anonymous Online Contributor
In how many different medical clinics is this trial being run today?
"This study is currently looking for participants at 100 clinical trial sites. While the primary locations are in Edina, Milwaukee and Kansas City, there are also many other centres located throughout America. To cut down on participant burden, it is recommended that you select a site near to your home." - Anonymous Online Contributor
Are investigators looking for more participants at this time?
"Yes, this is accurate. The clinicaltrials.gov website contains information indicating that the trial is currently recruiting patients. This study was originally posted on 11/29/2021 and was last updated on 8/11/2022. They are looking to recruit 306 patients from 100 different sites." - Anonymous Online Contributor