Actively Recruiting
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
Led by Jasper Gerritsen · Updated on 2023-11-27
1015
Participants Needed
8
Research Sites
313 weeks
Total Duration
On this page
Sponsors
J
Jasper Gerritsen
Lead Sponsor
H
Haaglanden Medical Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older up to 90 years
- Diagnosis of high-grade glioma (WHO grade III or IV) confirmed by MRI assessed by a neurosurgeon
- Ability to provide written informed consent
You will not qualify if you...
- Tumors located in the cerebellum, brainstem, or midline
- Inability to provide written informed consent
- High-grade glioma caused by malignant transformation from low-grade glioma
- Second primary cancer within the past 5 years, except adequately treated in situ carcinoma or basal cell carcinoma of the skin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
University Hospital Leuven
Leuven, Belgium
Actively Recruiting
4
Technical University Munich
Munich, Bavaria, Germany, 74076
Not Yet Recruiting
5
University Hospital Heidelberg
Heidelberg, Germany
Actively Recruiting
6
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
7
Haaglanden Medical Centre
The Hague, South Holland, Netherlands, 2512 VA
Actively Recruiting
8
Inselspital Universitätsspital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
Research Team
J
Jasper Gerritsen, MD PhD
CONTACT
A
Arnaud Vincent, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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