Comparing palliative care and surgery for high-grade glioma patients
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
This study is testing whether palliative care or surgery helps people with high-grade glioma live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1015 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT06146738 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of palliative care versus biopsy and resection on survival and quality of life in patients with high-grade glioma. It is an international, multicenter, prospective observational study that treats patients in a 1:3:3 ratio across three arms. The primary objectives include measuring overall survival and quality of life at multiple time points using standardized questionnaires. The study aims to identify which subset of patients may benefit most from surgical intervention versus palliative care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 years diagnosed with high-grade glioma and able to provide informed consent.
Not a fit: Patients with tumors located in the cerebellum, brainstem, or midline, or those with secondary high-grade gliomas or recent second primary malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment options for high-grade glioma patients, potentially improving their survival and quality of life.
How similar studies have performed: Other studies have explored similar treatment comparisons in glioma patients, but this specific approach is novel in its focus on quality of life alongside survival outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 7 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University Hospital Leuven — Leuven, Belgium (Recruiting)
- Technical University Munich — Munich, Bavaria, Germany (Not_yet_recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
- Haaglanden Medical Centre — The Hague, South Holland, Netherlands (Recruiting)
- Inselspital Universitätsspital Bern — Bern, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Jasper Gerritsen, MD PhD — Erasmus Medical Center
- Study coordinator: Jasper Gerritsen, MD PhD
- Email: j.gerritsen@erasmusmc.nl
- Phone: 31107036130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.