Quality-of-Life Assessment for Glioblastoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Kaiser Permanente Dublin, Dublin, CAGlioblastoma+1 MoreQuality-of-Life Assessment - Other
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Glioblastoma
  • Gliosarcoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 4 years

Year 4
Overall Survival
Year 4
Progression Free Survival (PFS)
Up to 4 years
Absolute lymphocyte counts
Incidence of Adverse Events
Patient reported outcomes for Brain Tumors

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
48%Blood or bone marrow
42%Metabolic or laboratory-testing result
40%Hepatic
36%General
28%Constitutional symptoms
26%Neurologic
22%Pulmonary
21%Gastrointestinal
19%Renal or genitourinary
19%Arrhythmia
13%Pain
8%Infection or febrile neutropenia
7%Skin
7%Musculoskeletal
2%Death
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT00019682) in the Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin) ARM group. Side effects include: Blood or bone marrow with 48%, Metabolic or laboratory-testing result with 42%, Hepatic with 40%, General with 36%, Constitutional symptoms with 28%.

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

ARM II (radiation therapy, temozolomide, lomustine)Experimental Group · 5 Interventions: Lomustine, Photon Beam Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Temozolomide · Intervention Types: Drug, Radiation, Other, Other, Drug
Arm I (radiation therapy, temozolomide)ActiveComparator Group · 4 Interventions: Photon Beam Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Temozolomide · Intervention Types: Radiation, Other, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomustine
FDA approved
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

NRG OncologyLead Sponsor
221 Previous Clinical Trials
95,554 Total Patients Enrolled
13 Trials studying Glioblastoma
4,160 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,155 Previous Clinical Trials
41,163,274 Total Patients Enrolled
306 Trials studying Glioblastoma
22,394 Patients Enrolled for Glioblastoma
Fabio M IwamotoPrincipal InvestigatorNRG Oncology

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

Does this trial seek octogenarian participants?

"This trial's age requirements for participation are between 18 and 70 years old." - Anonymous Online Contributor

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.