Collaborator:
Odense University Hospital, Sahlgrenska University Hospital, Sweden, Turku University Hospital, Karolinska University Hospital, Norwegian University of Science and Technology, University Hospital, Linkoeping, Uppsala University Hospital, University Hospital, Ume
Studienleiter
Asgeir S Jakola, MD, PhD Principal Investigator St.Olavs University Hospital and Sahlgrenska University Hospital Geir Bråthen, MD, PhD Study Director St. Olavs Hospital
Medical University of Vienna Vienna AustriaRekrutierend» Google-Maps Ansprechpartner: Georg Widhalm E-Mail: georg.widhalm@meduniwien.ac.at» Ansprechpartner anzeigenOdense University Hospital Odense DenmarkRekrutierend» Google-Maps Ansprechpartner: Frants R Poulsen E-Mail: frantz.r.poulsen@rsyd.dk
Christian Bonde Pedersen E-Mail: Christian.bonde@rsyd.dk» Ansprechpartner anzeigenHelsinki University Hospital Helsinki FinlandRekrutierend» Google-Maps Ansprechpartner: Jarno Satopää E-Mail: jarno.satopaa@hus.fi
3. Neurological function (Time Frame - Early postoperative (i.e. prior to radiotherapy) to 36 months): Neurological assessment in Neuro-Oncology (NANO) Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a tumor within the central nervous system. The NANO is composed of 9 items. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NANO scale score. The maximum possible score is 23, with the minimum score being a 0.
4. Health-related quality of life assessed by EQ-5D 3L (Time Frame - Early postoperative (i.e. prior to radiotherapy) to 36 months): The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
5. Health-related quality of life assessed by EORTC QLQ C30 (Time Frame - Early postoperative (i.e. prior to radiotherapy) to 36 months): The QLQ-C30 is a cancer health-related quality-of-life questionnaire that has been widely used in clinical trials and investigations using PROs for individual patient management. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Most items use a "past week" recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.
6. Health-related quality of life assessed by BN20 (Time Frame - Early postoperative (i.e. prior to radiotherapy) to 36 months): The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BN20 is a quality of life assessment specific to brain neoplasms. Consists of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = "not at all" to 4 = "very much." Higher score means worse outcome.
7. Neurocognition (Time Frame - Early postoperative (i.e. prior to radiotherapy) to 36 months): The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
8. Surgical complication (Time Frame - 30 days): surgical complication grade 3, 4 and 5, assessed using the Dindo-Clavien classification
9. Proportion with contrast remnant (Time Frame - Within 72 hours postoperative): Resection proportion with contrast remnant
10. Extent of resection, T2/FLAIR remnant (Time Frame - Within 72 hours postoperative): Proportion with remnant in terms of hyper intensity changes in T2/FLAIR
11. Margin of resection (Time Frame - Within 72 hours postoperative): Cavity volume/contrast enhancement volume
Active Comparator: Conventional surgery Aim of gross total resection (i.e. removal of contrast enhancing tumor) according to institutional practice. No limit in use of technical adjuncts in this arm.
Experimental: Supramarginal surgery Aim of supramarginal resection, where a margin of at least 10 mm is considered feasible prior to surgery. The resection is guided by the T2 volume (i.e. zone of edema) where removal of as much as possible of this zone (or beyond) is attempted as long as considered safe
Supramarginal resection: Aim of supramarginal resection, where a margin of at least 10 mm is considered feasible prior to surgery. The resection is guided by the T2 volume (i.e. zone of edema) where removal of as much as possible of this zone (or beyond) is attempted as long as considered safe
Conventional surgery: Aim of gross total resection (i.e. removal of contrast enhancing tumor) according to institutional practice. No limit in use of technical adjuncts in this arm.
Quelle: ClinicalTrials.gov
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