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NCT06146738: PALSUR

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

Recruiting now Last updated 27 November 2023
What this trial tests

trial testing Palliative Care in Glioblastoma in 1,015 participants. Currently enrolling.

Timeline
1 January 2023
Primary endpoint
1 January 2028
1 January 2029

Quick facts

Lead sponsorJasper Gerritsen
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment1,015
Start date1 January 2023
Primary completion1 January 2028
Estimated completion1 January 2029
Sites8 locations across Netherlands, Belgium, Germany, Switzerland, United States

Drugs / interventions tested

Conditions studied

Sponsor

Jasper Gerritsen

Who can join

Adults 18 to 90, any sex, with Glioblastoma or Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Palliative Care

Trials testing the same drug.

Other recruiting trials for Glioblastoma

Currently open trials in the same condition.

Other Jasper Gerritsen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06146738.

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