Glioblastoma Clinical Trial
— Intellance1Official 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)
Verified date | May 2023 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AbbVie | Radiation Therapy Oncology Group |
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,
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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