Back to resultsIntraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme (INTRAGO-II)
Primary Purpose
Glioblastoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Standard surgery
Intraoperative radiotherapy
Radiochemotherapy
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Intraoperative Radiotherapy, Radiotherapy Dose Escalation
Eligibility Criteria
Inclusion Criteria
- Age ≥18 and ≤ 80 years
- Karnofsky Performance Score (KPS) ≥ 60%
- Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
- Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
- Patient's written IC obtained at least 24h prior to surgery
- For women with childbearing potential: adequate contraception
Patients must have adequate organ functions
Bone marrow function:
- Platelets ≥ 75.000/μL
- WBC ≥ 3.000/μL
- Hemoglobin ≥ 10.0 g/dL
Liver Function:
- ASAT and ALAT ≤ 3.0 times ULN
- ALP ≤ 2.5 times ULN
- Total Serum Bilirubin < 1.5 times ULN
Renal Function:
- Serum Creatinine ≤ 1.5 times ULN
Inclusion Criteria Related to Surgery:
- IORT must be technically feasible
- Histology supports diagnosis of GBM
Exclusion Criteria
- Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
- Previous cranial radiation therapy
- Cytostatic therapy / chemotherapy for cancer within the past 5 years
- History of cancers or other comorbidities that limit life expectancy to less than five years
- Previous therapy with anti-angiogenic substances (such as bevacizumab)
- Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
- Participation in other clinical trials testing cancer-derived investigational agents/procedures.
- Pregnant or breast feeding patients
Fertile patients refusing to use safe contraceptive methods during the study
Exclusion Criteria Related to Surgery:
- Active egress of fluids from a ventricular defect
- In-field risk organs and/or IORT dose >8 Gy to any risk organ
Sites / Locations
- Barrow Neurological Institute (SJHMC)
- Stritch School of Medicine Loyola UniversityRecruiting
- Long Island Jewish Medical Center, North Shore University HospitalRecruiting
- Lenox Hill Hospital, Hofstra Northwell School of MedicineRecruiting
- West Virginia UniversityRecruiting
- Hospital Alemão Oswaldo CruzRecruiting
- Montreal Neurological Institute and HospitalRecruiting
- Beijing Tian Tan Hospital, Capital Medical UniversityRecruiting
- University Hospital AugsburgRecruiting
- Charité - UniversitätsmedizinRecruiting
- St. Georg HospitalRecruiting
- University Hospital MannheimRecruiting
- Technical University of Munich (TUM), Department of Radiation OncologyRecruiting
- Klinikum StuttgartRecruiting
- Helios University Hospital WuppertalRecruiting
- Gangnam Severance Hospital, Yonsei University College of MedicineRecruiting
- Catalan Institute of Oncology (ICO)Recruiting
- Hospital Reina SofiaRecruiting
- The London Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Arm (A)
Control Arm (B)
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Median Progression-Free Survival
Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
Secondary Outcome Measures
Median Overall Survival
PFS within a 1-2 cm margin around the cavity
Determined by serial contrast-enhanced MRI scans using modified RANO criteria and serial perfusion imaging
OS with respect to Age
Median overall survival of patients <65 vs. ≥ 65 years
PFS with respect to Age
Progression-free survival of patients <65 vs. ≥ 65 years; determined according to modified RANO criteria and serial perfusion imaging
OS with respect to KPS
Median overall survival of patients with KPS 80-100% vs. 60-70%
PFS with respect to KPS
Progression-free survival of patients with KPS 80-100% vs. 60-70%; determined according to modified RANO criteria and serial perfusion imaging
OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
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)
PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
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
OS with respect to extent of resection
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)
PFS with respect to extent of resection
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)
OS with respect to MGMT promoter methylation status
OS in patients with promoter methylation vs. no promoter methylation
PFS with respect to MGMT promoter methylation status
PFS in patients with promoter methylation vs. no promoter methylation; determined according to modified RANO criteria and serial perfusion imaging
Quality of Life (QoL) questionnaire
Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).
Change in functional outcomes as measured by BI from its baseline value.
Radiation-related (acute / early delayed / late) neurotoxicity
Assessed by regular neurological examinations and serial MRI scans
Full Information
NCT ID
NCT02685605
First Posted
February 5, 2016
Last Updated
May 9, 2023
Sponsor
Universitätsmedizin Mannheim
Collaborators
Carl Zeiss Meditec AG, University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02685605
Brief Title
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
Acronym
INTRAGO-II
Official Title
A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsmedizin Mannheim
Collaborators
Carl Zeiss Meditec AG, University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioblastoma, Intraoperative Radiotherapy, Radiotherapy Dose Escalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm (A)
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Arm (B)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Standard surgery
Intervention Type
Radiation
Intervention Name(s)
Intraoperative radiotherapy
Other Intervention Name(s)
IORT
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiochemotherapy
Intervention Description
EBRT to 60 Gy plus 75 mg/m2/d temozolomide
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Primary Outcome Measure Information:
Title
Median Progression-Free Survival
Description
Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Median Overall Survival
Time Frame
24 Months
Title
PFS within a 1-2 cm margin around the cavity
Description
Determined by serial contrast-enhanced MRI scans using modified RANO criteria and serial perfusion imaging
Time Frame
24 Months
Title
OS with respect to Age
Description
Median overall survival of patients <65 vs. ≥ 65 years
Time Frame
24 Months
Title
PFS with respect to Age
Description
Progression-free survival of patients <65 vs. ≥ 65 years; determined according to modified RANO criteria and serial perfusion imaging
Time Frame
24 Months
Title
OS with respect to KPS
Description
Median overall survival of patients with KPS 80-100% vs. 60-70%
Time Frame
24 Months
Title
PFS with respect to KPS
Description
Progression-free survival of patients with KPS 80-100% vs. 60-70%; determined according to modified RANO criteria and serial perfusion imaging
Time Frame
24 Months
Title
OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Description
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)
Time Frame
24 Months
Title
PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Description
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
Time Frame
24 Months
Title
OS with respect to extent of resection
Description
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)
Time Frame
24 Months
Title
PFS with respect to extent of resection
Description
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)
Time Frame
24 Months
Title
OS with respect to MGMT promoter methylation status
Description
OS in patients with promoter methylation vs. no promoter methylation
Time Frame
24 Months
Title
PFS with respect to MGMT promoter methylation status
Description
PFS in patients with promoter methylation vs. no promoter methylation; determined according to modified RANO criteria and serial perfusion imaging
Time Frame
24 Months
Title
Quality of Life (QoL) questionnaire
Description
Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
Time Frame
24 Months
Title
Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).
Description
Change in functional outcomes as measured by BI from its baseline value.
Time Frame
24 Months
Title
Radiation-related (acute / early delayed / late) neurotoxicity
Description
Assessed by regular neurological examinations and serial MRI scans
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age ≥18 and ≤ 80 years
Karnofsky Performance Score (KPS) ≥ 60%
Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
Patient's written IC obtained at least 24h prior to surgery
For women with childbearing potential: adequate contraception
Patients must have adequate organ functions
Bone marrow function:
Platelets ≥ 75.000/μL
WBC ≥ 3.000/μL
Hemoglobin ≥ 10.0 g/dL
Liver Function:
ASAT and ALAT ≤ 3.0 times ULN
ALP ≤ 2.5 times ULN
Total Serum Bilirubin < 1.5 times ULN
Renal Function:
Serum Creatinine ≤ 1.5 times ULN
Inclusion Criteria Related to Surgery:
IORT must be technically feasible
Histology supports diagnosis of GBM
Exclusion Criteria
Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
Previous cranial radiation therapy
Cytostatic therapy / chemotherapy for cancer within the past 5 years
History of cancers or other comorbidities that limit life expectancy to less than five years
Previous therapy with anti-angiogenic substances (such as bevacizumab)
Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
Participation in other clinical trials testing cancer-derived investigational agents/procedures.
Pregnant or breast feeding patients
Fertile patients refusing to use safe contraceptive methods during the study
Exclusion Criteria Related to Surgery:
Active egress of fluids from a ventricular defect
In-field risk organs and/or IORT dose >8 Gy to any risk organ
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Nesper-Brock, PhD
Phone
+49-621-383
Ext
3530
Email
martina.nesper-brock@umm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Office UMM
Phone
+49-621-383
Ext
3498
Email
strahlentherapie.studien@umm.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank A. Giordano, MD
Organizational Affiliation
Department of Radiation Oncology, University Hospital Bonn, Univeristy of Bonn, Bonn, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Petrecca, MD
Organizational Affiliation
Department of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute (SJHMC)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Arnold
Email
Lisa.Arnold@DignityHealth.org
First Name & Middle Initial & Last Name & Degree
Norissa Honea, RN, PhD
Phone
+1-602-406
Ext
6267
Email
Norissa.Honea@dignityhealth.org
First Name & Middle Initial & Last Name & Degree
Kris A. Smith, MD
First Name & Middle Initial & Last Name & Degree
Michael Lawton, MD
Facility Name
Stritch School of Medicine Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth A Chiappetta, RN, BSN, CCRP
Phone
708-216
Ext
2568
Email
BCHIAPPETTA@lumc.edu
First Name & Middle Initial & Last Name & Degree
Abhishek Solanki, MD
Facility Name
Long Island Jewish Medical Center, North Shore University Hospital
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise A Purcell, MS ANP-C CCRN-CMC
Phone
+1 516-941
Ext
1263
Email
LPurcell@northwell.edu
First Name & Middle Initial & Last Name & Degree
Michael Schulder, MD
Facility Name
Lenox Hill Hospital, Hofstra Northwell School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamika A Wong, MPH
Phone
212-434-4836
Email
twong4@northwell.edu
First Name & Middle Initial & Last Name & Degree
John A. Boockvar, MD
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Brunetti
Phone
304-293-7360
First Name & Middle Initial & Last Name & Degree
Christopher P Cifarelli, MD, PhD, FAANS, FACS
Facility Name
Hospital Alemão Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Guedes de Castro, MD
Email
dougguedes@uol.com.br
First Name & Middle Initial & Last Name & Degree
Douglas Guedes de Castro, MD
First Name & Middle Initial & Last Name & Degree
Rodrigo Hanriot, MD
Facility Name
Montreal Neurological Institute and Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Petrecca, MD, PhD
Phone
514-398
Ext
2591
Email
kevin.petrecca@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Kevin Petrecca, MD
First Name & Middle Initial & Last Name & Degree
Luis Souhami, MD
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengkai Zhang
Email
ckzhanghs@163.com
First Name & Middle Initial & Last Name & Degree
Zhan Xue, MD
Facility Name
University Hospital Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Schill, PhD
Phone
+49 821 400 25 42
Email
Sabine.Schill@klinikum-augsburg.de
First Name & Middle Initial & Last Name & Degree
Klaus H Kahl, MD
Facility Name
Charité - Universitätsmedizin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Runewitz
Phone
+49 30 450 617
Ext
434
Email
susanne.runewitz@charite.de
First Name & Middle Initial & Last Name & Degree
Peter Vajkoczy, MD
First Name & Middle Initial & Last Name & Degree
Julia Onken, MD
First Name & Middle Initial & Last Name & Degree
Axel Madlung, MD
Facility Name
St. Georg Hospital
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Sorge, MD
Email
Oliver.Sorge@sanktgeorg.de
First Name & Middle Initial & Last Name & Degree
Anna Hedwig Müller
Email
Anna-Hedwig.Mueller@SanktGeorg.de
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Studienzentrale Strahlentherapie
Phone
00496213834960
Email
Studien.Strahlen@medma.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Michael Ehmann, MD
First Name & Middle Initial & Last Name & Degree
Nima Etminan, MD
Facility Name
Technical University of Munich (TUM), Department of Radiation Oncology
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Kessel, PhD
Phone
+49 89 4140-4501
Email
carmen.kessel@tum.de]
First Name & Middle Initial & Last Name & Degree
Stephanie E Combs, MD
Facility Name
Klinikum Stuttgart
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrike Arzbach
Phone
+49 711/ 278-33700
Email
u.arzbach@klinikum-stuttgart.de
First Name & Middle Initial & Last Name & Degree
Oliver Ganslandt, MD
First Name & Middle Initial & Last Name & Degree
Marc Münter, MD
Facility Name
Helios University Hospital Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mareike Schultes
Phone
+49 (202) 896 23
Ext
97
Email
Mareike.Schultes@helios-gesundheit.de
First Name & Middle Initial & Last Name & Degree
Marc Piroth, MD
Facility Name
Gangnam Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ik Jae Lee, MD
Phone
+82-2-2019
Ext
3152
Email
IKJAE412@YUHS.AC
First Name & Middle Initial & Last Name & Degree
Ik Jae Lee, MD
Facility Name
Catalan Institute of Oncology (ICO)
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montserrat Ventura Bujalance
Phone
+ 34 93 260 77 22
Email
montseventura@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Ferran Guedea, MD, PhD
Facility Name
Hospital Reina Sofia
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Garcia Cabezas, MD
Email
songar1@gmail.com
First Name & Middle Initial & Last Name & Degree
Juan Solivera Vela, MD
Email
juan.solivera@gmail.com
Facility Name
The London Clinic
City
London
ZIP/Postal Code
W1G 6BW
Country
United Kingdom
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
25535398
Citation
Giordano FA, Brehmer S, Abo-Madyan Y, Welzel G, Sperk E, Keller A, Schneider F, Clausen S, Herskind C, Schmiedek P, Wenz F. INTRAGO: intraoperative radiotherapy in glioblastoma multiforme-a phase I/II dose escalation study. BMC Cancer. 2014 Dec 22;14:992. doi: 10.1186/1471-2407-14-992.
Results Reference
background
PubMed Identifier
31629553
Citation
Sarria GR, Sperk E, Han X, Sarria GJ, Wenz F, Brehmer S, Fu B, Min S, Zhang H, Qin S, Qiu X, Hanggi D, Abo-Madyan Y, Martinez D, Cabrera C, Giordano FA. Intraoperative radiotherapy for glioblastoma: an international pooled analysis. Radiother Oncol. 2020 Jan;142:162-167. doi: 10.1016/j.radonc.2019.09.023. Epub 2019 Oct 16.
Results Reference
background
PubMed Identifier
37150259
Citation
Ayala Alvarez DS, Watson PGF, Popovic M, Heng VJ, Evans MDC, Panet-Raymond V, Seuntjens J. Evaluation of Dosimetry Formalisms in Intraoperative Radiation Therapy of Glioblastoma. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):763-773. doi: 10.1016/j.ijrobp.2023.04.031. Epub 2023 May 5.
Results Reference
background
PubMed Identifier
34858846
Citation
Cifarelli CP, Jacobson GM. Intraoperative Radiotherapy in Brain Malignancies: Indications and Outcomes in Primary and Metastatic Brain Tumors. Front Oncol. 2021 Nov 11;11:768168. doi: 10.3389/fonc.2021.768168. eCollection 2021.
Results Reference
background
PubMed Identifier
34778080
Citation
Sarria GR, Smalec Z, Muedder T, Holz JA, Scafa D, Koch D, Garbe S, Schneider M, Hamed M, Vatter H, Herrlinger U, Giordano FA, Schmeel LC. Dosimetric Comparison of Upfront Boosting With Stereotactic Radiosurgery Versus Intraoperative Radiotherapy for Glioblastoma. Front Oncol. 2021 Oct 28;11:759873. doi: 10.3389/fonc.2021.759873. eCollection 2021.
Results Reference
background
PubMed Identifier
29528443
Citation
Giordano FA, Brehmer S, Murle B, Welzel G, Sperk E, Keller A, Abo-Madyan Y, Scherzinger E, Clausen S, Schneider F, Herskind C, Glas M, Seiz-Rosenhagen M, Groden C, Hanggi D, Schmiedek P, Emami B, Souhami L, Petrecca K, Wenz F. Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma (INTRAGO): An Open-Label, Dose-Escalation Phase I/II Trial. Neurosurgery. 2019 Jan 1;84(1):41-49. doi: 10.1093/neuros/nyy018.
Results Reference
derived
Learn more about this trial
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
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