There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment.
This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). 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
Medical reasons precluding MRI (e.g. pacemaker)
Inability to give written informed consent
Secondary high-grade glioma due to malignant transformation from low-grade glioma
Patients with primary high-grade glioma 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
Tumor resection
Procedure/SurgeryMaximal safe resection of the tumor
Tumor biopsy
Procedure/SurgeryBiopsy of the tumor
Overall survival
Time from diagnosis to death from any cause
Adjuvant treatment with chemotherapy and radiotherapy
Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery
Progression-free survival
Time from diagnosis to disease progression (occurrence of a new tumor lesions with a volume greater than 0.175 cm3, or an increase in residual tumor volume of more than 25%) or death, whichever comes first
Neurological morbidity at 6 weeks
NIHSS deterioration of 1 point or more at 6 weeks after surgery
Neurological morbidity at 3 months
NIHSS deterioration of 1 point or more at 3 months after surgery
Neurological morbidity at 6 months
NIHSS deterioration of 1 point or more at 6 months after surgery
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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
