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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure, Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
View:

• Age ≥18 years and ≤90 years

• Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon

• Written informed consent

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Other Locations
Belgium
University Hospital Leuven
RECRUITING
Leuven
Germany
University Hospital Heidelberg
RECRUITING
Heidelberg
Technical University Munich
NOT_YET_RECRUITING
Munich
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Haaglanden Medical Centre
RECRUITING
The Hague
Switzerland
Inselspital Universitätsspital Bern
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Jasper Gerritsen, MD PhD
j.gerritsen@erasmusmc.nl
31107036130
Backup
Arnaud Vincent, MD PhD
a.vincent@erasmusmc.nl
31107034211
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 1015
Treatments
Palliative Care
Best supportive care without surgical intervention
Tumor biopsy
Tumor biopsy
Tumor resection
Maximal safe resection of the tumor
Sponsors
Leads: Jasper Gerritsen
Collaborators: Massachusetts General Hospital, Universitaire Ziekenhuizen KU Leuven, Insel Gruppe AG, University Hospital Bern, Technical University of Munich, University of California, San Francisco, Haaglanden Medical Centre, University Hospital Heidelberg

This content was sourced from clinicaltrials.gov