Collaborator:
Carl Zeiss Meditec AG, University of California, Los Angeles,
Studienleiter
Frank A. Giordano, MD Principal Investigator Department of Radiation Oncology, University Hospital Bonn, Univeristy of Bonn, Bonn, Germany Kevin Petrecca, MD Principal Investigator Department of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada
University Hospital Mannheim 68167 Mannheim (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Studienzentrale Strahlentherapie Phone: 00496213834960 E-Mail: Studien.Strahlen@medma.uni-heidelberg.de» Ansprechpartner anzeigenTechnical University of Munich (TUM), Department of Radiation Oncology 81675 Munich (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Carmen Kessel, PhD Phone: +49 89 4140-4501 E-Mail: carmen.kessel@tum.de]» Ansprechpartner anzeigenBrustzentrum Klinikum Stuttgart/Frauenklinik Kriegsbergstraße 60 70174 Stuttgart DeutschlandRekrutierend» Google-Maps Ansprechpartner: Ulrike Arzbach Phone: +49 711/ 278-33700 E-Mail: u.arzbach@klinikum-stuttgart.de» Ansprechpartner anzeigenHelios University Hospital Wuppertal 42283 Wuppertal (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Mareike Schultes Phone: +49 (202) 896 23 Phone (ext.): 97 E-Mail: Mareike.Schultes@helios-gesundheit.de» Ansprechpartner anzeigenBarrow Neurological Institute (SJHMC) 85013 Phoenix United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Lisa Arnold E-Mail: Lisa.Arnold@DignityHealth.org
Norissa Honea, RN, PhD Phone: +1-602-406 Phone (ext.): 6267 E-Mail: Norissa.Honea@dignityhealth.org» Ansprechpartner anzeigenStritch School of Medicine Loyola University 60153 Maywood United StatesRekrutierend» Google-Maps Ansprechpartner: Beth A Chiappetta, RN, BSN, CCRP Phone: 708-216 Phone (ext.): 2568 E-Mail: BCHIAPPETTA@lumc.edu» Ansprechpartner anzeigenLong Island Jewish Medical Center, North Shore University Hospital 11042 Lake Success United StatesRekrutierend» Google-Maps Ansprechpartner: Louise A Purcell, MS ANP-C CCRN-CMC Phone: +1 516-941 Phone (ext.): 1263 E-Mail: LPurcell@northwell.edu» Ansprechpartner anzeigenLenox Hill Hospital, Hofstra Northwell School of Medicine 10028 New York United StatesRekrutierend» Google-Maps Ansprechpartner: Tamika A Wong, MPH Phone: 212-434-4836 E-Mail: twong4@northwell.edu» Ansprechpartner anzeigenWest Virginia University 26506-9260 Morgantown United StatesRekrutierend» Google-Maps Ansprechpartner: Joseph Brunetti Phone: 304-293-7360» Ansprechpartner anzeigenHospital Alemão Oswaldo Cruz 01323-020 São Paulo BrazilRekrutierend» Google-Maps Ansprechpartner: Douglas Guedes de Castro, MD E-Mail: dougguedes@uol.com.br» Ansprechpartner anzeigenMontreal Neurological Institute and Hospital H3A 2B4 Montréal CanadaRekrutierend» Google-Maps Ansprechpartner: Kevin Petrecca, MD, PhD Phone: 514-398 Phone (ext.): 2591 E-Mail: kevin.petrecca@mcgill.ca» Ansprechpartner anzeigenBeijing Tian Tan Hospital, Capital Medical University 100050 Beijing ChinaRekrutierend» Google-Maps Ansprechpartner: Chengkai Zhang E-Mail: ckzhanghs@163.com» Ansprechpartner anzeigenGangnam Severance Hospital, Yonsei University College of Medicine 06273 Seoul Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner: Ik Jae Lee, MD Phone: +82-2-2019 Phone (ext.): 3152 E-Mail: IKJAE412@YUHS.AC» Ansprechpartner anzeigenCatalan Institute of Oncology (ICO) 08908 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Montserrat Ventura Bujalance Phone: + 34 93 260 77 22 E-Mail: montseventura@iconcologia.net» Ansprechpartner anzeigenHospital Reina Sofia Córdoba SpainRekrutierend» Google-Maps Ansprechpartner: Sonia Garcia Cabezas, MD E-Mail: songar1@gmail.com
Juan Solivera Vela, MD E-Mail: juan.solivera@gmail.com» Ansprechpartner anzeigenThe London Clinic W1G 6BW London United KingdomAktiv, nicht rekrutierend» Google-Maps
1. Median Progression-Free Survival (Time Frame - 24 Months): Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
Secondary outcome:
1. Median Overall Survival (Time Frame - 24 Months)
2. PFS within a 1-2 cm margin around the cavity (Time Frame - 24 Months): Determined by serial contrast-enhanced MRI scans using modified RANO criteria and serial perfusion imaging
3. OS with respect to Age (Time Frame - 24 Months): Median overall survival of patients <65 vs. ≥ 65 years
4. PFS with respect to Age (Time Frame - 24 Months): Progression-free survival of patients <65 vs. ≥ 65 years; determined according to modified RANO criteria and serial perfusion imaging
5. OS with respect to KPS (Time Frame - 24 Months): Median overall survival of patients with KPS 80-100% vs. 60-70%
6. PFS with respect to KPS (Time Frame - 24 Months): Progression-free survival of patients with KPS 80-100% vs. 60-70%; determined according to modified RANO criteria and serial perfusion imaging
7. OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin (Time Frame - 24 Months): Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. <0.5 cm)
8. PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin (Time Frame - 24 Months): Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. <0.5 cm); determined according to modified RANO criteria and serial perfusion imaging
9. OS with respect to extent of resection (Time Frame - 24 Months): Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. OS will be calculated for the following groups:
Max Diameter group 0: 0 cm (no residual tumor)
Max Diameter group 1: >0 to ≤1.5 cm (cumulative if multiple residual lesions)
Max Diameter group 2: >1.5 cm (cumulative if multiple residual lesions)
10. PFS with respect to extent of resection (Time Frame - 24 Months): Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. PFS will be determined according to modified RANO criteria and serial perfusion imaging for the following groups:
Max Diameter group 0: 0 cm (no residual tumor)
Max Diameter group 1: >0 to ≤1.5 cm (cumulative if multiple residual lesions)
Max Diameter group 2: >1.5 cm (cumulative if multiple residual lesions)
11. OS with respect to MGMT promoter methylation status (Time Frame - 24 Months): OS in patients with promoter methylation vs. no promoter methylation
12. PFS with respect to MGMT promoter methylation status (Time Frame - 24 Months): PFS in patients with promoter methylation vs. no promoter methylation; determined according to modified RANO criteria and serial perfusion imaging
13. Quality of Life (QoL) questionnaire (Time Frame - 24 Months): Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
14. Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965). (Time Frame - 24 Months): Change in functional outcomes as measured by BI from its baseline value.
15. Radiation-related (acute / early delayed / late) neurotoxicity (Time Frame - 24 Months): Assessed by regular neurological examinations and serial MRI scans
Experimental: Experimental Arm (A) Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Active Comparator: Control Arm (B) Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Intraoperative radiotherapy (IORT): Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.
Radiochemotherapy: EBRT to 60 Gy plus 75 mg/m2/d temozolomide
Temozolomide: Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Quelle: ClinicalTrials.gov
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"Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme"
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