Glioblastoma Clinical Trial
— RESBIOPOfficial title:
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
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.
Status | Recruiting |
Enrollment | 564 |
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. Medical reasons precluding MRI (e.g. pacemaker) 3. Inability to give written informed consent 4. Secondary high-grade glioma due to malignant transformation from low-grade glioma 5. 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 Center | The Hague | |
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 | Adjuvant treatment with chemotherapy and radiotherapy | Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery | 6 months postoperatively | |
Secondary | 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 | Up to 5 years postoperatively | |
Secondary | Neurological morbidity at 6 weeks | NIHSS deterioration of 1 point or more at 6 weeks after surgery | 6 weeks postoperatively | |
Secondary | Neurological morbidity at 3 months | NIHSS deterioration of 1 point or more at 3 months after surgery | 3 months postoperatively | |
Secondary | Neurological morbidity at 6 months | NIHSS deterioration of 1 point or more at 6 months after surgery | 6 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 3 months (EORTC QLQ C30) | Quality of life as assessed by the EORTC QLQ C30 questionnaire | 3 months 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 weeks (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 6 weeks postoperatively | |
Secondary | Quality of life at 3 months (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 3 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 weeks (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 6 weeks postoperatively | |
Secondary | 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 months (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 6 months postoperatively | |
Secondary | Serious Adverse Events | Serious Adverse Events within 6 weeks postoperatively | 6 weeks postoperatively |
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