NCT06146738Recruiting

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.

Inclusion criteria

1. Age ≥18 years and ≤90 years 2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon 3. Written informed consent

Exclusion criteria

1. Tumors of the cerebellum, brainstem or midline 2. Inability to give written informed consent 3. Secondary high-grade glioma due to malignant transformation from low-grade glioma 4. 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

Contacts

The trial team's contact details are shown on request.

See the official trial record

Status: Recruiting
Phase: —
Study type: Observational
Countries: Switzerland, Germany, United States, Belgium, Netherlands
Sponsor: Jasper Gerritsen(Other)
Protocol no.: MEC-2020-0812-4
Conditions: Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Adult
Interventions: Behavioral, Procedure

Treatments studied

Palliative Care
Tumor biopsy
Tumor resection

Collaborators

Haaglanden Medical Centre, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, Technical University of Munich, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, University of California, San Francisco

Locations · 6

Heidelberg, GermanyUniversity Hospital HeidelbergRecruiting at this site
San Francisco, United StatesUniversity of California, San FranciscoRecruiting at this site
Boston, United StatesMassachusetts General HospitalRecruiting at this site
Leuven, BelgiumUniversity Hospital LeuvenRecruiting at this site
Rotterdam, NetherlandsErasmus Medical CenterRecruiting at this site
The Hague, NetherlandsHaaglanden Medical CentreRecruiting at this site

In total, worldwide, 6 of the 8 sites listed in the registry are recruiting; the other 2 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: November 27, 2023).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other versions

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