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

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.

Conditions

• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma, IDH-wildtype
• Glioblastoma Multiforme, Adult

Interventions

BEHAVIORAL

Palliative Care

Best supportive care without surgical intervention

PROCEDURE

Tumor biopsy

Tumor biopsy

PROCEDURE

Tumor resection

Maximal safe resection of the tumor

Sponsors & Collaborators

• Haaglanden Medical Centre

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Jasper Gerritsen

  lead OTHER

Principal Investigators

• Jasper Gerritsen, MD PhD · Erasmus Medical Center

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2028-01-01

Completion

2029-01-01

Countries

• United States
• Belgium
• Germany
• Netherlands
• Switzerland

Study Locations