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NCT06146738Recruiting

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

Source: ClinicalTrials.gov · Last updated 27 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1015 (estimated)
First submitted
18 Nov 2023
Start date
1 Jan 2023
Primary completion date
1 Jan 2028
Lead sponsor
Jasper Gerritsen
Diseases
Glioblastoma
NCT number
NCT06146738

What you commit to

  • Study type: Observational
  • Planned participants: 1015
  • From 1 Jan 2023 to the primary completion date, 1 Jan 2028
  • 8 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Tumors of the cerebellum, brainstem or midline
  • Inability to give written informed consent

Who the study is looking for

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

Age in the registry: 18 years to 90 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Inselspital Universitätsspital Bern
Coordinator of this site? Confirm its status
BernSwitzerlandNot yet recruiting
University Hospital Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyRecruiting
Technical University Munich
Coordinator of this site? Confirm its status
MunichGermanyNot yet recruiting
Erasmus Medical Center
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Haaglanden Medical Centre
Coordinator of this site? Confirm its status
The HagueNetherlandsRecruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.