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
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Inselspital Universitätsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Not yet recruiting |
| University Hospital Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Technical University Munich Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Haaglanden Medical Centre Coordinator of this site? Confirm its status | The Hague | Netherlands | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.