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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006146-26 | EudraCT Number |
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This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + RT + Temozolomide | Experimental | In the Concurrent Phase participants will receive radiotherapy (RT) in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they receive six 28-day cycle of bevacizumab 10 mg/kg IV q2w and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive bevacizumab 15 mg/kg IV q3w until disease progression/unacceptable toxicity. |
|
| Placebo + RT + Temozolomide | Placebo Comparator | In the Concurrent Phase participants will receive radiotherapy in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they will receive six 28-day cycle of placebo IV q2w and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive placebo IV q3w until disease progression/unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator | PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization [WHO] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging [MRI] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment. | Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) |
| Co-Primary: Overall Survival (OS) | Overall Survival was defined as the time from randomization to death due to any cause. | Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS as Assessed by an Independent Review Facility | An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as >=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham; Neuro-Oncology | Birmingham | Alabama | 35294 | United States | ||
| UCLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36346112 | Derived | Seliger C, Oppong FB, Lefranc F, Chinot O, Stupp R, Nabors B, Gorlia T, Weller M; EORTC Brain Tumor Group. Association of antidepressant drug use with outcome of patients with glioblastoma. Int J Cancer. 2023 Apr 1;152(7):1348-1359. doi: 10.1002/ijc.34344. Epub 2022 Nov 17. | |
| 35842871 | Derived | Hagiwara A, Schlossman J, Shabani S, Raymond C, Tatekawa H, Abrey LE, Garcia J, Chinot O, Saran F, Nishikawa R, Henriksson R, Mason WP, Wick W, Cloughesy TF, Ellingson BM. Incidence, molecular characteristics, and imaging features of "clinically-defined pseudoprogression" in newly diagnosed glioblastoma treated with chemoradiation. J Neurooncol. 2022 Sep;159(3):509-518. doi: 10.1007/s11060-022-04088-3. Epub 2022 Jul 17. |
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The primary completion date for co-primary outcome of Progression-Free Survival (PFS) was 31 Mar 2012, whereas, the primary completion date for co-primary outcome of Overall Survival (OS) was 28 Feb 2013. Data for PFS and OS are reported according to these cut-off dates.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + RT + Temozolomide | In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Concurrent Phase |
|
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|
| Temozolomide | Drug | 75 mg/m^2 once daily for 6 weeks, followed by 150-200 mg/m^2 once daily on days 1-5 of six 4 week cycles. |
|
| Radiation therapy | Radiation | 30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks. |
|
| Placebo | Drug | Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase. |
|
| Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months]) |
| Kaplan-Meier (KM) Estimate of One Year Overall Survival | KM estimate of one year overall survival (probability to survive for at least 1 year) was reported. Corresponding 95% confidence interval (CI) was calculated using Greenwood's formula. | Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) |
| Kaplan-Meier (KM) Estimate of Two Year Overall Survival | KM estimate of two year overall survival was reported (probability to survive for at least 2 years). Corresponding 95% CI was calculated using Greenwood's formula. | Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) |
| PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20) | EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; & global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL >/=10 points for functioning/global health status, & decrease of >/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction & communication deficit (BN20). PFS: randomization to PD or death. PD: >=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening. | Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) |
| Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death | An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as AE.A serious adverse event (SAE) is any experience that suggests a significant hazard,contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Non-serious adverse events (Non-SAEs) included all AEs except SAEs (non-SAEs = all AEs - SAEs). Nine participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for Safety. | Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months]) |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr | Evanston | Illinois | 60201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Hatton Research Institutes | Cincinnati | Ohio | 45220 | United States |
| Sarah Cannon Cancer Center and Research Institute | Nashville | Tennessee | 37203 | United States |
| University of Virgina | Charlottesville | Virginia | 22908 | United States |
| Prince of Wales Hospital; Department of Medical Oncology | Randwick | New South Wales | 2031 | Australia |
| North Shore Private Hospital; Northern Specialist Centre | St Leonards | New South Wales | 2065 | Australia |
| Royal North Shore Hospital; Department of Medical Oncology | St Leonards | New South Wales | 2065 | Australia |
| Princess AleXandra Hospital; Department of Medical Oncology | Woolloongabba | Queensland | 4102 | Australia |
| Calvary North Adelaide; North Adeliade Oncology Centre | North Adelaide | South Australia | 5006 | Australia |
| Royal Melbourne Hospital; Hematology and Medical Oncology | Parkville | Victoria | 3052 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Clin Univ de Bxl Hôpital Erasme | Brussels | 1070 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| AZ Sint Lucas (Sint Lucas) | Ghent | 9000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| AZ Delta (Campus Wilgenstraat) | Roeselare | 8800 | Belgium |
| Tom Baker Cancer Centre-Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute ; Dept of Medical Oncology | Edmonton | Alberta | T6G 1Z2 | Canada |
| BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology | Vancouver | British Columbia | V5Z 4E6 | Canada |
| CancerCare Manitoba; Neuro-Oncology | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Hamilton Health Sciences - Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Centre of Southeastern Ontario; Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital Regional Cancer Centre; Neuro-Oncology | Ottawa | Ontario | K1H 1C4 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727 | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University; Montreal Neurological Institute; Oncology | Montreal | Quebec | H3A 2B4 | Canada |
| Chuq - Hopital Hotel Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Saskatoon Cancer Centre; Uni of Saskatoon Campus | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd. | Aalborg | 9000 | Denmark |
| Righospitalet, Hæmatologisk Klinik | København Ø | 2100 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense | 5000 | Denmark |
| Hopital Avicenne; Rhumatologie | Bobigny | 93009 | France |
| Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale | Bordeaux | 33075 | France |
| Institut Bergonie; Gastro Enterologie Oncologie | Bordeaux | 33076 | France |
| Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie | Bron | 69677 | France |
| Centre Jean Perrin; Hopital De Jour | Clermont-Ferrand | 63011 | France |
| Hopital Beaujon; Oncologie | Clichy | 92118 | France |
| Centre Georges François Leclerc | Dijon | 21000 | France |
| Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage | Marseille | 13385 | France |
| Centre Val Aurelle Paul Lamarque; Medecine B3 | Montpellier | 34298 | France |
| Hôpital Central; Departement de Neuro-Oncologie | Nancy | 54000 | France |
| Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin | Paris | 75651 | France |
| Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie | Dresden | 01307 | Germany |
| Justus-Liebig-Universität Giessen; Neurochirurgische Klinik | Giessen | 35392 | Germany |
| Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie | Hamburg | 20246 | Germany |
| Universitatsklinikum Heidelberg; Abteilung Neuroonkologie | Heidelberg | 69120 | Germany |
| Ärztehaus Velen | Ibbenbühren | 49479 | Germany |
| Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie | Mainz | 55131 | Germany |
| Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie | München | 81377 | Germany |
| Univ General Hosp Heraklion; Medical Oncology | Heraklion | 711 10 | Greece |
| University Hospital of Larissa; Oncology | Larissa | 41 110 | Greece |
| Papageorgiou General Hospital; Medical Oncology | Thessaloniki | 546 29 | Greece |
| Dr Stephen Yau; Clinical oncology | Hong Kong | Hong Kong |
| Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre | Hong Kong | Hong Kong |
| Queen Mary Hospital; Microbiology Dept. | Hong Kong | Hong Kong |
| Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | H-1134 | Hungary |
| Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery | Miskolc | 3526 | Hungary |
| Pécsi Tudományegyetem Áok; Onkoterapias Intezet | Pécs | 7623 | Hungary |
| Rambam Medical Center; Oncology | Haifa | 3525408 | Israel |
| Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology | Jerusalem | 91120 | Israel |
| Rabin MC; Davidof Center - Oncology Institute | Petah Tikva | 4941492 | Israel |
| Chaim Sheba MC; Pediatric Hematology Oncology | Tel Litwinsky | 52621 | Israel |
| Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica | Bologna | Emilia-Romagna | 40139 | Italy |
| Ospedale Bufalini | Forlì | Emilia-Romagna | 47023 | Italy |
| Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica | Milan | Lombardy | 20133 | Italy |
| Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia | Turin | Piedmont | 10126 | Italy |
| Az. Osp. S. Maria; Dept. Di Oncologia Medica | Terni | Umbria | 05100 | Italy |
| Ospedale di Treviso, Universita di Padova; Neurosurgery Dept | Treviso | Veneto | 31100 | Italy |
| Hiroshima University Hospital; Neurosurgery | Hiroshima | 734-8551 | Japan |
| Tsukuba University Hospital; Neurology | Ibaraki | 305-8576 | Japan |
| Kumamoto University Hospital; Neurosurgery | Kumamoto | 860-8556 | Japan |
| Kitano Hospital; Neurosurgery | Osaka | 530-8480 | Japan |
| Saitama Medical University International Medical Center; Clinical and Medical Oncology | Saitama | 350-1298 | Japan |
| National Cancer Center Hospital; Neurosurgery | Tokyo | 104-0045 | Japan |
| Komagome Hospital; Neurosurgery | Tokyo | 113-8677 | Japan |
| Kyorin University Hospital; Neurosurgery | Tokyo | 181-8611 | Japan |
| VU MEDISCH CENTRUM; Dept. of Medical Oncology | Amsterdam | 1081 HV | Netherlands |
| Catharina Ziekenhuis; Dept of Internal Medicin | Eindhoven | 5623 EJ | Netherlands |
| Utrecht University Medical Centre; Dept of Medical Oncology and UPC | Utrecht | 3584 CW | Netherlands |
| Auckland city hospital; Auckland Regional Cancer Centre and Blood Service | Auckland | 1023 | New Zealand |
| Christchurch Hospital; Dept of Oncology | Christchurch | New Zealand |
| Waikato Hospital; Regional Cancer Center | Hamilton | New Zealand |
| Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | Bialystok | 15-027 | Poland |
| Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii | Bydgoszcz | 85-796 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi | Lublin | 20-954 | Poland |
| IPO de Coimbra; Servico de Oncologia Medica | Coimbra | 3000-075 | Portugal |
| IPO de Lisboa; Servico de Neurologia | Lisbon | 1099-023 | Portugal |
| Hospital de Santa Maria; Servico de Oncologia Medica | Lisbon | 1649-035 | Portugal |
| Hospital de Sao Joao; Servico de Oncologia | Porto | 4200-319 | Portugal |
| Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie | Bucharest | 022328 | Romania |
| Institut Oncologic Ion Chiricuta; Departament Radioterapie | Cluj-Napoca | 400015 | Romania |
| Spital Clinic Judetean Mures; Oncologie | Târgu Mureş | 540142 | Romania |
| N.N.Burdenko Main Military Clinical Hospital; Oncology Dept | Moscow | 105229 | Russia |
| Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery | Moscow | 115478 | Russia |
| Scientific Research Neurosurgery Institute; Dept. of Neurooncology | Moscow | 125047 | Russia |
| Institution of Higher Professional Learning Military; Neurooncology | Saint Petersburg | 194175 | Russia |
| Pusan National University Hospital; Neuro Sugery | Busan | 602-739 | South Korea |
| Kyungpook National University Hosital; Neuro Sugery | Daegu | 700-721 | South Korea |
| National Cancer Centre; Neurosurgery Dept | Goyang-si | 410-769 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology | Seoul | 03080 | South Korea |
| Asan Medical Center; Medical Oncology | Seoul | 05505 | South Korea |
| Yonsei University Severance Hospital; Medical Oncology | Seoul | 120-752 | South Korea |
| Samsung Medical Center; Neurosurgery Department | Seoul | 135-170 | South Korea |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | 08036 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Barcelona | 08916 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Regional Universitario Carlos Haya; Servicio de Oncologia | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| Sahlgrenska Universitetssjukhuset; Jubileumskliniken | Gothenburg | 413 45 | Sweden |
| Skånes University Hospital, Skånes Department of Onclology | Lund | 22185 | Sweden |
| Norrlands Universitetssjukhus; Cancer Centrum | Umeå | 901 85 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 75185 | Sweden |
| HUG; Oncologie | Geneva | 1211 | Switzerland |
| Queen Elizabeth Medical Centre; Neurosurgery | Birmingham | B15 2TT | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| The Royal Marsden NHS Foundation Trust; Oncology | London | SW3 6JJ | United Kingdom |
| The Clatterbridge Cancer Ctr For Oncolgy | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Northern Centre for Cancer Care;Oncology | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham City Hospital; Dept of Haematology | Nottingham | NG5 1PB | United Kingdom |
| Queen's Hospital; Oncology | Romford | RM7 0AG | United Kingdom |
| Weston Park Hospital; Cancer Clinical Trials Centre | Sheffield | S10 2SJ | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| 34980260 | Derived | Jiguet-Jiglaire C, Boissonneau S, Denicolai E, Hein V, Lasseur R, Garcia J, Romain S, Appay R, Graillon T, Mason W, Carpentier AF, Brandes AA, Ouafik L', Wick W, Baaziz A, Gigan JP, Arguello RJ, Figarella-Branger D, Chinot O, Tabouret E. Plasmatic MMP9 released from tumor-infiltrating neutrophils is predictive for bevacizumab efficacy in glioblastoma patients: an AVAglio ancillary study. Acta Neuropathol Commun. 2022 Jan 3;10(1):1. doi: 10.1186/s40478-021-01305-4. |
| 27006178 | Derived | Chinot OL, Nishikawa R, Mason W, Henriksson R, Saran F, Cloughesy T, Garcia J, Revil C, Abrey L, Wick W. Upfront bevacizumab may extend survival for glioblastoma patients who do not receive second-line therapy: an exploratory analysis of AVAglio. Neuro Oncol. 2016 Sep;18(9):1313-8. doi: 10.1093/neuonc/now046. Epub 2016 Mar 22. |
| 26809751 | Derived | Saran F, Chinot OL, Henriksson R, Mason W, Wick W, Cloughesy T, Dhar S, Pozzi E, Garcia J, Nishikawa R. Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy. Neuro Oncol. 2016 Jul;18(7):991-1001. doi: 10.1093/neuonc/nov300. Epub 2016 Jan 24. |
| 26014298 | Derived | Taphoorn MJ, Henriksson R, Bottomley A, Cloughesy T, Wick W, Mason WP, Saran F, Nishikawa R, Hilton M, Theodore-Oklota C, Ravelo A, Chinot OL. Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma. J Clin Oncol. 2015 Jul 1;33(19):2166-75. doi: 10.1200/JCO.2014.60.3217. Epub 2015 May 26. |
| 24552318 | Derived | Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345. |
| 23529375 | Derived | Chinot OL, Macdonald DR, Abrey LE, Zahlmann G, Kerloeguen Y, Cloughesy TF. Response assessment criteria for glioblastoma: practical adaptation and implementation in clinical trials of antiangiogenic therapy. Curr Neurol Neurosci Rep. 2013 May;13(5):347. doi: 10.1007/s11910-013-0347-2. |
| FG001 | Placebo + RT + Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Phase |
|
|
| Monotherapy Phase |
|
|
| After Primary Overall Survival Analysis |
|
|
Intent to treat population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + RT + Temozolomide | In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
| BG001 | Placebo + RT +Temozolomide | In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator | PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization [WHO] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging [MRI] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment. | Intent to treat population. | Posted | Median | 95% Confidence Interval | Months | Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Co-Primary: Overall Survival (OS) | Overall Survival was defined as the time from randomization to death due to any cause. | Intent to treat population. | Posted | Median | 95% Confidence Interval | Months | Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS as Assessed by an Independent Review Facility | An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as >=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment. | Intent to treat population. | Posted | Median | 95% Confidence Interval | Months | Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier (KM) Estimate of One Year Overall Survival | KM estimate of one year overall survival (probability to survive for at least 1 year) was reported. Corresponding 95% confidence interval (CI) was calculated using Greenwood's formula. | Intent to treat population. | Posted | Number | 95% Confidence Interval | probability of being alive | Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier (KM) Estimate of Two Year Overall Survival | KM estimate of two year overall survival was reported (probability to survive for at least 2 years). Corresponding 95% CI was calculated using Greenwood's formula. | Intent to treat population. | Posted | Number | 95% Confidence Interval | probability of being alive | Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months]) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20) | EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; & global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL >/=10 points for functioning/global health status, & decrease of >/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction & communication deficit (BN20). PFS: randomization to PD or death. PD: >=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening. | Intent to treat population. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category. | Posted | Median | Full Range | Months | Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death | An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as AE.A serious adverse event (SAE) is any experience that suggests a significant hazard,contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Non-serious adverse events (Non-SAEs) included all AEs except SAEs (non-SAEs = all AEs - SAEs). Nine participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for Safety. | Safety Population included all randomized participants who received study treatment during the treatment period (10 participants did not receive at least one dose of study treatment and were therefore excluded, 4 in Placebo and 6 in Bevacizumab. | Posted | Number | Participants | Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months]) |
|
Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
Safety Population.10 participants did not receive at least 1 dose of drug and were excluded, 4 in Placebo and 6 in Bevacizumab.9 participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for safety.Other AEs are non-SAEs (AEs excluding SAEs).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab + RT+Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. | 179 | 461 | 437 | 461 | ||
| EG001 | Placebo + RT+Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. | 115 | 450 | 412 | 450 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Graft infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Basal ganglia stroke | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyramidal tract syndrome | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anal prolapse | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Delirium tremens | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Scrotal cyst | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Metastasis to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Optic Neuropathy | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Extradural Abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
Not provided
Not provided
| Refused treatment/Did not cooperate |
|
| Administrative reasons |
|
| Failure to return |
|
| Refused treatment/ Did not cooperate |
|
| Withdrew Consent |
|
| Failure to return |
|
| Progression of Disease |
|
| Withdrew Consent |
|
| Male |
|
|
|
|
| OG001 | Placebo + RT + Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
|
|
|
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
|
|
In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
|
|
| OG001 | Placebo + RT + Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
|
|
| OG001 | Placebo + RT + Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
|
|