A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Glioblastoma Clinical Trial

— Intellance1  

Official title:

A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573324
• Other study ID #: M13-813
• Secondary ID: 2015-001166-26
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2015
• Est. completion date: April 4, 2022

Study information

• Verified date: May 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Must have a clinical diagnosis of glioblastoma (GBM).

• Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.

• Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).

• Must have recovered from effects of surgery, postoperative infection and other complications of surgery.

• Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).

Exclusion Criteria:

• Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).

• Prior chemo therapy or radiosensitizer for head and neck cancer.

• Prior radiotherapy to the head or neck in overlap of radiation fields.

• Prior therapy for glioblastoma or other invasive malignancy.

• Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Related Conditions & MeSH terms

• Glioblastoma
• Gliosarcoma

Intervention

Drug:
• Temozolomide
Oral Capsule
• Depatuxizumab mafodotin
Intravenous (IV) Infusion

Radiation:
• Radiation

Drug:
• Placebo for ABT-414
IV Infusion (IV)

Locations

Country	Name	City	State
Argentina	Duplicate_Instituto Med Alex Flem /ID# 142884	Buenos Aires
Argentina	Sanatorio Parque /ID# 142825	Rosario	Santa Fe
Australia	Calvary North Adelaide Hospita /ID# 143866	Adelaide	South Australia
Australia	Royal Adelaide Hospital /ID# 143867	Adelaide	South Australia
Australia	St Vincent's Hospital Melbourne /ID# 143858	Fitzroy Melbourne	Victoria
Australia	Duplicate_Austin Hospital /ID# 143859	Heidelberg	Victoria
Australia	Liverpool Hospital /ID# 144392	Liverpool	New South Wales
Australia	Duplicate_The Prince of Wales Hospital /ID# 144882	Randwick	New South Wales
Australia	Royal North Shore Hospital /ID# 143870	St Leonards	New South Wales
Australia	St John Of God Subiaco Hospital /ID# 143869	Subiaco	Western Australia
Australia	Calvary Mater Newcastle /ID# 143860	Waratah	New South Wales
Australia	Southern Medical Day Care Centre /ID# 143868	Wollongong	New South Wales
Australia	Princess Alexandra Hospital /ID# 143857	Woolloongabba	Queensland
Austria	Medizinische Universitaet Graz /ID# 141982	Graz	Steiermark
Austria	Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984	Innsbruck
Austria	Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983	Linz
Austria	Medizinische Universitaet Wien /ID# 141981	Vienna	Wien
Belgium	Grand Hopital de Charleroi /ID# 141645	Charleroi	Hainaut
Belgium	UZ Gent /ID# 141647	Gent	Oost-Vlaanderen
Belgium	Duplicate_Centre Hospitalier Jolimont /ID# 143873	La Louvière
Belgium	Universitair Ziekenhuis Leuven /ID# 143872	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 162860	Liege
Belgium	UCL Saint-Luc /ID# 141648	Woluwe-Saint-Lambert	Bruxelles-Capitale
Belgium	Duplicate_UCL Mont Godinne /ID# 141644	Yvoir
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876	Barretos	Sao Paulo
Brazil	Liga Norte Riograndense Contra o Câncer /ID# 143878	Natal	Rio Grande Do Norte
Brazil	Hospital Sao Lucas da PUCRS /ID# 143879	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877	Rio de Janeiro
Brazil	Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031	São Paulo	Sao Paulo
Canada	QE II Health Sciences Centre /ID# 151600	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre /ID# 152117	Hamilton	Ontario
Canada	Victoria Hospital /ID# 144184	London	Ontario
Canada	Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315	Montreal	Quebec
Canada	Duplicate_Jewish General Hospital /ID# 144029	Montreal	Quebec
Canada	Royal Victoria Hospital / McGill University Health Centre /ID# 144187	Montreal	Quebec
Canada	CHUM - Notre-Dame Hospital /ID# 144027	Montréal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 150120	Ottawa	Ontario
Canada	CHU de Quebec-Universite Laval /ID# 144189	Quebec City	Quebec
Canada	CHUS - Hopital Fleurimont /ID# 149771	Sherbrooke	Quebec
Canada	Princess Margaret Cancer Centre /ID# 166277	Toronto	Ontario
Canada	Duplicate_Cancer Care Manitoba /ID# 149253	Winnipeg	Manitoba
China	Beijing Tian Tan Hospital, Capital Medical University /ID# 167160	Beijing
China	Peking Union Medical College Hospital /ID# 157430	Beijing	Beijing
China	SanboBrain Hospital Capital Medical University /ID# 166422	Beijing	Beijing
China	Duplicate_Xiangya Hospital Central South University /ID# 166791	Changsha	Hunan
China	The First Affiliated Hospital of Fujian Medical University /ID# 159166	Fuzhou
China	Sun Yat-Sen University Cancer Center /ID# 143919	Guangzhou	Guangdong
China	Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593	Hangzhou	Zhejiang
China	Anhui Provincial Hospital /ID# 166320	Hefei	Anhui
China	Duplicate_Huashan Hospital of Fudan University /ID# 159999	Shanghai	Shanghai
China	Duplicate_Shengjing Hospital of China Medical University /ID# 167016	Shenyang
China	The First Affiliated Hospital of Soochow University /ID# 165596	Suzhou	Jiangsu
China	Duplicate_Tianjin Med Univ General Hosp /ID# 143923	Tianjin
China	Tongji Hospital Tongji Medical College of HUST /ID# 163820	Wuhan	Hubei
China	Duplicate_Tangdu Hospital /ID# 143920	Xi'an	Shaanxi
Colombia	Administradora del Country_S.A-Clinica Del Country /ID# 143881	Bogota	Cundinamarca
Colombia	Centro Medico Imbanaco de Cali /ID# 143882	Cali
Colombia	Hospital Pablo Tobon Uribe /ID# 143780	Medellín	Antioquia
Colombia	Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223	Monteria	Cordoba
Colombia	Oncologos del Occidente S.A /ID# 147713	Pereira	Risaralda
Czechia	Masarykuv onkologicky ustav /ID# 143884	Brno
Czechia	Duplicate_FN Hradec Kralove /ID# 143885	Hradec Kralove
Czechia	Krajska nemocnice Liberec, a.s. /ID# 142024	Liberec
Czechia	Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883	Ostrava
Czechia	Fakultni Nemocnice v Motole /ID# 142023	Praha
France	Insititut de Cancerologie /ID# 143908	Angers
France	Hopital Avicenne - APHP /ID# 143910	Bobigny	Ile-de-France
France	CHRU Lille - Hopital Claude Huriez /ID# 143915	Lille	Hauts-de-France
France	AP-HM - Hopital de la Timone /ID# 143911	Marseille CEDEX 05	Bouches-du-Rhone
France	CHU Nice -Hopital Pasteur /ID# 143916	Nice CEDEX 1	Provence-Alpes-Cote-d Azur
France	Hopital Pitie Salpetriere /ID# 143917	Paris
France	Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914	St Herblain CEDEX	Loire-Atlantique
France	Duplicate_Gustave Roussy /ID# 143912	Villejuif Cedex	Ile-de-France
Germany	Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961	Bochum
Germany	Universitaetsklinik Heidelberg /ID# 143927	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Leipzig /ID# 143962	Leipzig	Sachsen
Germany	Universitaetsklinikum Tuebingen /ID# 143926	Tubingen	Baden-Wuerttemberg
Hong Kong	Prince of Wales Hospital /ID# 143952	Hong Kong
Ireland	Beaumont Hospital /ID# 142969	Beaumont	Dublin
Israel	Rambam Health Care Campus /ID# 143959	Haifa
Israel	Gastroenterology Institute, Division of Medicine /ID# 143958	Jerusalem
Israel	Rabin Medical Center /ID# 143957	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 143960	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 143956	Tel Aviv-Yafo	Tel-Aviv
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800	Milan
Italy	Istituto Oncologico Veneto /ID# 143821	Padova
Italy	Duplicate_Regina Elena National Cancer I /ID# 141795	Rome
Italy	Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801	Turin	Piemonte
Korea, Republic of	National Cancer Center /ID# 141845	Goyang	Gyeonggido
Korea, Republic of	Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 143887	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 143886	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844	Seoul
Mexico	Centro Medico Zambrano Hellion /ID# 143845	San Pedro Garza Garcia	Nuevo Leon
Netherlands	Vrije Universiteit Medisch Centrum /ID# 143889	Amsterdam
Netherlands	Haaglanden Medisch Centrum /ID# 141405	Den Haag
Netherlands	Universitair Medisch Centrum Groningen /ID# 141408	Groningen
Netherlands	Maastricht Universitair Medisch Centrum /ID# 143585	Maastricht
Netherlands	Universitair Medisch Centrum Utrecht /ID# 141406	Utrecht
New Zealand	Duplicate_Canterbury District Health Boa /ID# 143861	Christchurch
New Zealand	Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890	Wellington
Portugal	CCA Braga - Hospital de Braga /ID# 141940	Braga
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939	Faro
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941	Lisboa
Portugal	IPO Lisboa FG, EPE /ID# 141938	Lisboa
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830	Porto
Russian Federation	Regional Clinical Hospital of Kaliningrad region /ID# 141702	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707	Moscow	Moskva
Russian Federation	Federal State Treatment and Rehabilitation center /ID# 141704	Moscow	Moskva
Russian Federation	GEMC - European Medical Center /ID# 141703	Moscow	Moskovskaya Oblast
Russian Federation	National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701	Moscow	Moskva
Russian Federation	State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706	Ufa	Kirovskaya Oblast
Russian Federation	Sverdlovsk Regional Oncology Dispensary /ID# 141700	Yekaterinburg	Sverdlovskaya Oblast
Singapore	National Cancer Ctr Singapore /ID# 143932	Singapore
Singapore	National University Hospital /ID# 143933	Singapore
South Africa	University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064	Bloemfontein	Free State
South Africa	Netcare Oncology Intervent Ctr /ID# 143951	Cape Town	Western Cape
South Africa	Rondebosch Oncology Center /ID# 143949	Cape Town	Western Cape
South Africa	Netcare Unitas Hospital /ID# 152936	Centurion	Gauteng
South Africa	The Oncology Centre /ID# 143950	Durban	Kwazulu-Natal
South Africa	Cape Town Oncology Trials /ID# 143948	Kraaifontein	Western Cape
Spain	Hospital Clinic de Barcelona /ID# 143906	Barcelona
Spain	Hospital Santa Creu i Sant Pau /ID# 143900	Barcelona
Spain	Hospital Clinico Universitario San Carlos /ID# 143901	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 143930	Madrid
Spain	Hospital Universitario HM Sanchinarro /ID# 143496	Madrid
Spain	Hospital Regional de Malaga /ID# 143902	Málaga	Malaga
Spain	Hospital General Universitario de Valencia /ID# 143903	Valencia
Switzerland	Kantonsspital Aarau AG /ID# 141885	Aarau	Aargau
Switzerland	Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936	Bellinzona
Switzerland	Inselspital, Universitätsspital Bern /ID# 141886	Bern
Switzerland	Universitatsspital Zurich /ID# 141887	Zurich	Zuerich
Taiwan	National Taiwan University Hospital /ID# 143940	Taipei City
Taiwan	Taipei Veterans General Hosp /ID# 143955	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 143941	Taoyuan City
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 154592	Birmingham
United Kingdom	Velindre University NHS Trust /ID# 141996	Cardiff
United Kingdom	Duplicate_NHS Tayside /ID# 141651	Dundee
United Kingdom	NHS Lothian /ID# 141802	Edinburgh
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 141653	Leeds
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 142652	London	London, City Of
United Kingdom	University College London Hospitals NHS Foundation Trust /ID# 142658	London
United Kingdom	Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999	Newcastle Upon Tyne
United Kingdom	Royal Marsden Hospital /ID# 142827	Sutton
United States	Emory Midtown Infectious Disease Clinic /ID# 144015	Atlanta	Georgia
United States	Piedmont Hospital /ID# 145892	Atlanta	Georgia
United States	Univ of Colorado Cancer Center /ID# 148194	Aurora	Colorado
United States	Austin Cancer Centers /ID# 151061	Austin	Texas
United States	St. Luke's Hospital /ID# 148191	Bethlehem	Pennsylvania
United States	Boca Raton Regional Hospital /ID# 163659	Boca Raton	Florida
United States	Dana-Farber Cancer Institute /ID# 148475	Boston	Massachusetts
United States	Massachusetts General Hospital /ID# 144145	Boston	Massachusetts
United States	Tufts Medical Center /ID# 145897	Boston	Massachusetts
United States	MD Anderson Cancer Center at Cooper - Camden /ID# 145891	Camden	New Jersey
United States	Medical University of South Carolina /ID# 144141	Charleston	South Carolina
United States	Levine Cancer Ins, Carolina Me /ID# 144124	Charlotte	North Carolina
United States	Northwestern University Feinberg School of Medicine /ID# 147895	Chicago	Illinois
United States	The University of Chicago Medical Center /ID# 144158	Chicago	Illinois
United States	University of Cincinnati /ID# 144164	Cincinnati	Ohio
United States	Cleveland Clinic Main Campus /ID# 144023	Cleveland	Ohio
United States	Duplicate_Univ Hosp Cleveland /ID# 144153	Cleveland	Ohio
United States	The Ohio State University /ID# 144016	Columbus	Ohio
United States	Baylor Sammons Cancer Center /ID# 155542	Dallas	Texas
United States	Henry Ford Health System /ID# 145896	Detroit	Michigan
United States	Wayne State University /ID# 145890	Detroit	Michigan
United States	NorthShore University HealthSystem /ID# 144017	Evanston	Illinois
United States	Associated Neurologists of Sou /ID# 147701	Fairfield	Connecticut
United States	Inova Health System /ID# 152956	Falls Church	Virginia
United States	Holy Cross Hospital /ID# 156764	Fort Lauderdale	Florida
United States	Parkview Research Ctr, Hosp /ID# 144150	Fort Wayne	Indiana
United States	Penn State University and Milton S. Hershey Medical Center /ID# 147525	Hershey	Pennsylvania
United States	The University of Texas Health Science Center at Houston /ID# 144013	Houston	Texas
United States	University of Texas MD Anderson Cancer Center /ID# 144018	Houston	Texas
United States	University of California, Los Angeles /ID# 149239	Los Angeles	California
United States	University of Southern California /ID# 147543	Los Angeles	California
United States	Univ of Wisconsin Hosp/Clinics /ID# 144167	Madison	Wisconsin
United States	Baptist Hospital Miami /ID# 152451	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital /ID# 144139	Milwaukee	Wisconsin
United States	Intermountain Medical Center /ID# 144142	Murray	Utah
United States	Rutgers Cancer Institute of New Jersey /ID# 148190	New Brunswick	New Jersey
United States	Yale University /ID# 144170	New Haven	Connecticut
United States	Columbia University Medical Center /ID# 144020	New York	New York
United States	Christiana Care Health Service /ID# 144127	Newark	Delaware
United States	Univ Oklahoma HSC /ID# 144161	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital /ID# 144140	Omaha	Nebraska
United States	University of Nebraska Medical Center /ID# 145899	Omaha	Nebraska
United States	Advent Health /ID# 144128	Orlando	Florida
United States	Fox Chase Cancer Center /ID# 145893	Philadelphia	Pennsylvania
United States	Thomas Jefferson University /ID# 144191	Philadelphia	Pennsylvania
United States	University of Pennsylvania /ID# 157623	Philadelphia	Pennsylvania
United States	St. Josephs Hospital and Med Center /ID# 144149	Phoenix	Arizona
United States	Allegheny General Hospital /ID# 144126	Pittsburgh	Pennsylvania
United States	University of Pennsylvania Medical Center - Shadyside /ID# 144159	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University Medical Center Main Hospital /ID# 149014	Richmond	Virginia
United States	University of Rochester Medical Center /ID# 144166	Rochester	New York
United States	Washington University-School of Medicine /ID# 144174	Saint Louis	Missouri
United States	Mmcorc /Id# 144146	Saint Louis Park	Minnesota
United States	University of Utah /ID# 144160	Salt Lake City	Utah
United States	Sharp Memorial Hospital /ID# 148193	San Diego	California
United States	Univ California, San Francisco /ID# 145889	San Francisco	California
United States	Duplicate_St. John's Health Center /ID# 148192	Santa Monica	California
United States	Maine Medical Partners Neurolo /ID# 160864	Scarborough	Maine
United States	University of Washington /ID# 144162	Seattle	Washington
United States	Virginia Mason Medical Center /ID# 144022	Seattle	Washington
United States	Highlands Oncology Group, PA /ID# 142050	Springdale	Arkansas
United States	Moffitt Cancer Center /ID# 144130	Tampa	Florida
United States	Duplicate_Scott and White Medical Center /ID# 160743	Temple	Texas
United States	University of Toledo /ID# 156763	Toledo	Ohio
United States	Northwestern Medicine Cancer Center - Warrenville /ID# 148476	Warrenville	Illinois
United States	Cedars-Sinai Medical Center-West Hollywood /ID# 148472	West Hollywood	California
United States	Univ Kansas Cancer Ctr - Overl /ID# 145895	Westwood	Kansas
United States	Duplicate_St. Joseph Mercy Hospital /ID# 144143	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Radiation Therapy Oncology Group

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czechia,  France,  Germany,  Hong Kong,  Ireland,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.; Unmethylated MGMT promoter is associated with a worse prognosis in GBM	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	OS for the MGMT Methylated Group	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	Progression-Free Survival (PFS)	PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	PFS for EGFRvIII-Mutated Tumor Subgroup	PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score	The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (= -1), stable (> -1 and < 1), and deteriorated (= 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by = 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	Deterioration Free Survival in MDASI-BT Symptom Interference Score	The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (= -1), stable (> -1 and < 1), and deteriorated (= 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by = 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary	Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score	The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

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