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.
Age ≥18 years and ≤90 years
Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
Written informed consent
Tumors of the cerebellum, brainstem or midline
Inability to give written informed consent
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
Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.
Cohort
Prospective
Palliative Care
BehavioralBest supportive care without surgical intervention
Tumor biopsy
Procedure/SurgeryTumor biopsy
Tumor resection
Procedure/SurgeryMaximal safe resection of the tumor
Overall survival
Time from diagnosis to death from any cause
Quality of life at 3 months (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Quality of life at 3 months (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Quality of life at 3 months (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Quality of life at 6 weeks (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Quality of life at 6 weeks (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Quality of life at 6 weeks (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Quality of life at 6 months (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
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Jasper Gerritsen
Lead sponsor
Erasmus Medical Center
Sponsor institution
Haaglanden Medical Centre
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
University Hospital Heidelberg
Collaborator
Technical University of Munich
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Massachusetts General Hospital
Collaborator
University of California, San Francisco
Collaborator
