The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
PALSUR
1 other identifier
observational
1,015
5 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 18, 2023
CompletedFirst Posted
Study publicly available on registry
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
November 27, 2023
November 1, 2023
5 years
November 18, 2023
November 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Overall survival
Time from diagnosis to death from any cause
Up to 5 years postoperatively
Quality of life at 3 months (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
3 months postoperatively
Quality of life at 3 months (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
3 months postoperatively
Quality of life at 3 months (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
3 months postoperatively
Secondary Outcomes (6)
Quality of life at 6 weeks (EORTC QLQ C30)
6 weeks postoperatively
Quality of life at 6 weeks (EORTC QLQ BN20)
6 weeks postoperatively
Quality of life at 6 weeks (EQ-5D)
6 weeks postoperatively
Quality of life at 6 months (EORTC QLQ C30)
6 months postoperatively
Quality of life at 6 months (EORTC QLQ BN20)
6 months postoperatively
- +1 more secondary outcomes
Study Arms (3)
Palliative Care
Best supportive care without surgical intervention
Tumor biopsy
Tumor biopsy
Tumor resection
Maximal safe resection of the tumor
Interventions
Best supportive care without surgical intervention
Eligibility Criteria
Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.
You may qualify if:
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
You may not qualify if:
- Tumors of the cerebellum, brainstem or midline
- Inability to give written informed consent
- Secondary high-grade glioma due to malignant transformation from low-grade glioma
- Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jasper Gerritsenlead
- Haaglanden Medical Centrecollaborator
- Universitaire Ziekenhuizen KU Leuvencollaborator
- University Hospital Heidelbergcollaborator
- Technical University of Munichcollaborator
- Insel Gruppe AG, University Hospital Berncollaborator
- Massachusetts General Hospitalcollaborator
- University of California, San Franciscocollaborator
Study Sites (8)
University of California, San Francisco
San Francisco, California, 94143, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University Hospital Leuven
Leuven, Belgium
Technical University Munich
Munich, Bavaria, 74076, Germany
University Hospital Heidelberg
Heidelberg, Germany
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD, Netherlands
Haaglanden Medical Centre
The Hague, South Holland, 2512 VA, Netherlands
Inselspital Universitätsspital Bern
Bern, 3010, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jasper Gerritsen, MD PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Jasper K.W. Gerritsen MD PhD
Study Record Dates
First Submitted
November 18, 2023
First Posted
November 27, 2023
Study Start
January 1, 2023
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
November 27, 2023
Record last verified: 2023-11