1015 Participants Needed

The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)

(PALSUR Trial)

Recruiting at 7 trial locations
JG
AV
Overseen ByArnaud Vincent, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jasper Gerritsen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

JG

Jasper Gerritsen, MD PhD

Principal Investigator

Erasmus Medical Center

Eligibility Criteria

Inclusion Criteria

You must be between 18 and 90 years old.
The tumor has been diagnosed as a high-grade glioma (HGG) based on an MRI scan assessed by the neurosurgeon.
You have given permission in writing to take part in the study.

Treatment Details

Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jasper Gerritsen

Lead Sponsor

Trials
5
Recruited
3,100+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Universitaire Ziekenhuizen KU Leuven

Collaborator

Trials
1,048
Recruited
1,658,000+

Haaglanden Medical Centre

Collaborator

Trials
18
Recruited
11,200+

University Hospital Heidelberg

Collaborator

Trials
258
Recruited
278,000+

Technical University of Munich

Collaborator

Trials
395
Recruited
813,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Insel Gruppe AG, University Hospital Bern

Collaborator

Trials
831
Recruited
2,353,000+