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Palliative Care for Glioblastoma (PALSUR Trial)

N/A
Recruiting
Led By Jasper Gerritsen, MD PhD
Research Sponsored by Jasper Gerritsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years postoperatively
Awards & highlights

PALSUR Trial Summary

There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

Eligible Conditions
  • Glioblastoma

PALSUR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Quality of life at 3 months (EORTC QLQ BN20)
Quality of life at 3 months (EORTC QLQ C30)
+1 more
Secondary outcome measures
Quality of life at 6 months (EORTC QLQ BN20)
Quality of life at 6 months (EORTC QLQ C30)
Quality of life at 6 months (EQ-5D)
+3 more

PALSUR Trial Design

3Treatment groups
Experimental Treatment
Group I: Tumor resectionExperimental Treatment1 Intervention
Maximal safe resection of the tumor
Group II: Tumor biopsyExperimental Treatment1 Intervention
Tumor biopsy
Group III: Palliative CareExperimental Treatment1 Intervention
Best supportive care without surgical intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palliative Care
2011
N/A
~1270
Tumor biopsy
2014
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,500 Previous Clinical Trials
15,235,456 Total Patients Enrolled
21 Trials studying Glioblastoma
3,106 Patients Enrolled for Glioblastoma
Universitaire Ziekenhuizen KU LeuvenOTHER
975 Previous Clinical Trials
1,620,384 Total Patients Enrolled
5 Trials studying Glioblastoma
2,490 Patients Enrolled for Glioblastoma
Insel Gruppe AG, University Hospital BernOTHER
768 Previous Clinical Trials
1,809,368 Total Patients Enrolled
8 Trials studying Glioblastoma
2,229 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~677 spots leftby Jan 2028