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The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
Who can join
Ages 18 to 90 · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Palliative Care (behavioral)
- Tumor biopsy (procedure)
- Tumor resection (procedure)
Sponsor: Jasper Gerritsen · Participants: 1,015 · Started: Jan 1, 2023
Contact the study team
- Jasper Gerritsen, MD PhD · Phone: 31107036130
- Arnaud Vincent, MD PhD · Phone: 31107034211
Official record on ClinicalTrials.gov — NCT06146738
Locations in the U.S.
| California | University of California, San Francisco, San Francisco |
| Massachusetts | Massachusetts General Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.