Glioblastoma Clinical Trial
— PALSUROfficial title:
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
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 | Recruiting |
Enrollment | 1015 |
Est. completion date | January 1, 2029 |
Est. primary completion date | January 1, 2028 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven | |
Germany | University Hospital Heidelberg | Heidelberg | |
Germany | Technical University Munich | Munich | Bavaria |
Netherlands | Erasmus Medical Center | Rotterdam | Zuid-Holland |
Netherlands | Haaglanden Medical Centre | The Hague | Zuid-Holland |
Switzerland | Inselspital Universitätsspital Bern | Bern | |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Jasper Gerritsen | Haaglanden Medical Centre, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, Technical University of Munich, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, University of California, San Francisco |
United States, Belgium, Germany, Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Time from diagnosis to death from any cause | Up to 5 years postoperatively | |
Primary | Quality of life at 3 months (EORTC QLQ C30) | Quality of life as assessed by the EORTC QLQ C30 questionnaire | 3 months postoperatively | |
Primary | Quality of life at 3 months (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 3 months postoperatively | |
Primary | Quality of life at 3 months (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 3 months postoperatively | |
Secondary | Quality of life at 6 weeks (EORTC QLQ C30) | Quality of life as assessed by the EORTC QLQ C30 questionnaire | 6 weeks postoperatively | |
Secondary | Quality of life at 6 weeks (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 6 weeks postoperatively | |
Secondary | Quality of life at 6 weeks (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 6 weeks postoperatively | |
Secondary | Quality of life at 6 months (EORTC QLQ C30) | Quality of life as assessed by the EORTC QLQ C30 questionnaire | 6 months postoperatively | |
Secondary | Quality of life at 6 months (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 6 months postoperatively | |
Secondary | Quality of life at 6 months (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 6 months postoperatively |
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