NCT06146738 The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
| NCT ID | NCT06146738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jasper Gerritsen |
| Condition | Glioblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,015 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,015 participants in total. It began in 2023-01-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Jasper Gerritsen, MD PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06146738 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06146738 currently recruiting?
Yes, NCT06146738 is actively recruiting participants. Contact the research team at j.gerritsen@erasmusmc.nl for enrollment information.
Where is the NCT06146738 trial being conducted?
This trial is being conducted at San Francisco, United States, Boston, United States, Leuven, Belgium, Munich, Germany and 4 additional locations.
Who is sponsoring the NCT06146738 clinical trial?
NCT06146738 is sponsored by Jasper Gerritsen. The principal investigator is Jasper Gerritsen, MD PhD at Erasmus Medical Center. The trial plans to enroll 1,015 participants.
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