Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction Clinical Trial
Official title:
A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction
Verified date | May 2022 |
Source | EMD Serono |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.
Status | Completed |
Enrollment | 499 |
Est. completion date | June 3, 2021 |
Est. primary completion date | September 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female participants greater than or equal to (>=) 18 years - Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Participants with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry - Estimated life expectancy of more than 12 weeks - Adequate haematological, hepatic and renal functions defined by the protocol - Negative blood pregnancy test at Screening for women of childbearing potential - Highly effective contraception for both male and female participants if the risk of conception exists - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Prior therapy with any antibody or drug targeting T-cell coregulatory proteins - Concurrent anticancer treatment or immunosuppressive agents - Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) - Tumor shown to be human epidermal growth factor 2 plus (HER2+) - Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the participant has not fully recovered from the surgery within 4 weeks of enrolment - Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of participants with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to <= 10 mg prednisone daily) - All participants with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, have not been progressing at least 2 months after completion of therapy, and no steroid maintenance therapy is required, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) - Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast) - Prior organ transplantation, including allogeneic stem-cell transplantation - Significant acute or chronic infections - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent - Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) - Persisting toxicity related to prior therapy except alopecia - Neuropathy Grade > 3 - Pregnancy or lactation - Known alcohol or drug abuse - History of uncontrolled intercurrent illness including hypertension, active infection, diabetes - Clinically significant (i.e., active) cardiovascular disease - All other significant diseases might impair the participant's tolerance of study treatment - Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements - Vaccination with live or live/attenuated viruses within 55 days of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines - Legal incapacity or limited legal capacity - Participants will be excluded from the Induction Phase and the Maintenance Phase if administration of their chemotherapy would be inconsistent with the current local labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or special provisions) for that chemotherapy. Investigators should check updated labelling via relevant websites at the time of entry into the Induction Phase and the Maintenance Phase - Other protocol defined exclusion criteria could apply |
Country | Name | City | State |
---|---|---|---|
Australia | Ballarat Base Hospital | Ballarat | Victoria |
Australia | Flinders Medical Centre | Bedford Park | South Australia |
Australia | Bendigo Hospital | Bendigo | Victoria |
Australia | Monash Medical Centre Clayton | Bentleigh | Victoria |
Australia | Box Hill Hospital | Box Hill | Victoria |
Australia | Lyell McEwin Hospital | Elizabeth Vale | South Australia |
Australia | Greenslopes Private Hospital | Greenslopes | Queensland |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Royal Hobart Hospital | Hobart | Tasmania |
Australia | St George Hospital | Kogarah | New South Wales |
Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
Australia | Border Medical Oncology | Wodonga | Victoria |
Brazil | Hospital Infanta Cristina | Badajoz | |
Brazil | Hospital de Câncer de Barretos-Fundação Pio XII | Barretos | Sao Paulo |
Brazil | Hospital São Lucas da PUCRS | Ijuí | Rio Grande Do Sul |
Brazil | Hospital Bruno Born | Lajeado | Rio Grande Do Sul |
Brazil | Oncosinos - Clínica de Oncologia - Hospital Regina | Novo Hamburgo | Rio Grande Do Sul |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Brazil | Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande Do Sul |
Brazil | IMV - Instituto De Medicina Vascular Hospital Mae de Deus | Porto Alegre | Sao Paulo |
Brazil | NOB - Núcleo de Oncologia da Bahia | Salvador | Bahia |
Brazil | CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia | Santo Andre | Sao Paulo |
Brazil | Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | Sao Paulo |
Brazil | ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira | São Paulo | Sao Paulo |
Canada | The Royal Victoria Hospital | Barrie | Ontario |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Cité de la Santé de Laval | Laval | Quebec |
Canada | McGill University - Dept. Oncology Clinical Research Program | Montréal | Quebec |
Canada | Humber River Hospital | Toronto | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
France | ICO - Site René Gauducheau | Angers Cedex 9 | Maine Et Loire |
France | CHU Besancon - Hopital Jean Minjoz | Besancon | Doubs |
France | CHU Bordeaux | Bordeaux Cedex | Gironde |
France | Hôpital Morvan | Brest | Brittany |
France | CHU Tours - Hôpital Trousseau | Chambray les Tours | Indre Et Loire |
France | CHU Clermont Ferrand | Clermont Ferrand cedex 1 | Puy De Dome |
France | Centre Georges François Leclerc | Dijon cedex | Côte-d'Or |
France | Clinique Victor Hugo - Centre Jean Bernard | Le Mans Cedex 02 | Sarthe |
France | Hôpital de la Timone | Marseille cedex 5 | Bouches Du Rhone |
France | Centre Antoine Lacassagne | Nice cedex 02 | Alpes Maritimes |
France | Hôpital Cochin | Paris cedex 14 | Paris |
France | Hôpital Européen Georges Pompidou | Paris Cedex 15 | Paris |
France | CRLCC Eugene Marquis | Rennes cedex | Ille Et Vilaine |
France | CHU de Toulouse - Hôpital Rangueil | Toulouse Cedex 9 | Haute Garonne |
Germany | Klinikum Esslingen GmbH | Esslingen A. N. | Baden Wuerttemberg |
Germany | Krankenhaus Nordwest GmbH | Frankfurt | Hessen |
Germany | Marienkrankenhaus Hamburg | Hamburg | |
Germany | Onkologische Schwerpunktpraxis Eppendorf | Hamburg | |
Germany | SLK-Kliniken Heilbronn GmbH | Heilbronn | Baden Wuerttemberg |
Germany | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | Rheinland Pfalz |
Germany | Klinikum Bogenhausen | Muenchen | Bayern |
Germany | Leopoldina Krankenhaus Schweinfurt | Schweinfurt | Bayern |
Hungary | Magyar Honvedseg Egeszsegugyi | Budapest | |
Hungary | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hajdú-Bihar |
Hungary | Petz Aladar Megyei Oktato Korhaz | Gyor | Gyor-Moson-Sopron |
Hungary | SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz | Nyiregyhaza | |
Hungary | Pecsi Tudomanyegyetem | Pecs | Baranya |
Hungary | Tolna Megyei Balassa Janos Korhaz | Szekszard | |
Hungary | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok | |
Hungary | Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | |
Italy | Presidio Ospedaliero Garibaldi Nesima | Catania | |
Italy | Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona) | Cremona | |
Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | |
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | |
Italy | IEO Istituto Europeo di Oncologia | Milano | |
Italy | Ospedale San Raffaele | Milano | |
Italy | Istituto Nazionale Tumori Fondazione G. Pascale | Napoli | |
Italy | Seconda Università degli Studi di Napoli | Napoli | |
Italy | IOV - Istituto Oncologico Veneto IRCCS | Padova | |
Italy | Ospedale degli Infermi | Rimini | |
Italy | Università Campus Bio-Medico di Roma | Roma | |
Italy | Azienda Ospedaliera S. Maria Di Terni | Terni | |
Italy | Azienda Ospedaliero-Universitaria Santa Maria della Misericordia | Udine | |
Japan | Chiba Cancer Center | Chiba-shi | Chiba-Ken |
Japan | Nat Cancer Ctr Hosp | Chuo-ku | Tokyo-To |
Japan | Saitama Medical University International Medical Center | Hidaka-shi | Saitama-Ken |
Japan | Izumi Municipal Hospital | Izumi-shi | Osaka |
Japan | Kagoshima University Medical And Dental Hospital | Kagoshima-shi | |
Japan | Kagawa University Hospital | Kita-gun | Kagawa-Ken |
Japan | Saitama Cancer Center | Kitaadachi-gun | Saitama-Ken |
Japan | Kumamoto University Hospital | Kumamoto-shi | Kumamoto-Ken |
Japan | Toranomon Hospital | Minato-ku | Tokyo-To |
Japan | Niigata Cancer Center Hospital | Niigata-shi | Niigata-Ken |
Japan | Kindai University Hospital | Osakasayama | Osaka-Fu |
Japan | Tohoku University Hospital | Sendai-shi | Miyagi-Ken |
Japan | Tochigi Cancer Center | Utsunomiya-shi | Tochigi-Ken |
Japan | Kanagawa Cancer Center | Yokohama-shi | Kanagawa-Ken |
Japan | Oita University Hospital | Yufu-shi | Oita-ken |
Korea, Republic of | Inje University Haeundae Paik Hospital | Busan | |
Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do |
Korea, Republic of | Keimyung University Dongsan Hospital | Daegu | Jung-gu |
Korea, Republic of | Kyungpook National University Medical Center | Daegu | |
Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun-gun | Jeollanam-do |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
Korea, Republic of | Yonsei University Health System | Seoul | |
Romania | S.C Oncopremium Team S.R.L | Baia Mare | |
Romania | Hifu Terramed Conformal SRL | Bucuresti | |
Romania | Institutul Clinic Fundeni | Bucuresti | |
Romania | Spitalul Clinic Coltea | Bucuresti | |
Romania | Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca | Cluj Napoca | Cluj |
Romania | S.C Radiotherapy Center Cluj S.R.L | Comuna Floresti | Cluj |
Romania | S.C Centrul de Oncologie Sf. Nectarie S.R.L | Craiova | Dolj |
Romania | Institutul Regional de Oncologie Iasi | Iasi | |
Romania | Spital Lotus SRL | Ploiesti | Prahova |
Romania | S.C Oncocenter Oncologie Clinica S.R.L | Timisoara | Timis |
Romania | S.C Oncomed S.R.L | Timisoara | Timis |
Russian Federation | SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" | Arkhangelsk | |
Russian Federation | LLC Evimed | Chelyabinsk | |
Russian Federation | RBIH "Ivanovo Regional Oncological Dispensary" | Ivanovo | |
Russian Federation | SBIH " Clinical Oncological Dispensary # 1" | Krasnodar | |
Russian Federation | FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" | Moscow | |
Russian Federation | BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | |
Russian Federation | SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary" | Pyatigorsk | |
Russian Federation | FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint-Petersburg | Leningrado |
Russian Federation | Pavlov First Saint Petersburg State Medical University | Saint-Petersburg | Leningrado |
Russian Federation | SPb SBIH "City Clinical Oncological Dispensary" | Saint-Petersburg | |
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Spain | ICO l´Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario HM Madrid Sanchinarro | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona |
Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | National Cheng Kung University Hospital | Tainan | |
Taiwan | Mackay Memorial Hospital | Taipei | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
Taiwan | Chang Gung Memorial Hospital, Linkou | Taoyuan | |
Thailand | Siriraj Hospital | Bangkok | |
Thailand | Maharaj Nakorn Chiang Mai Hospital | Muang | Chiang Mai |
Thailand | King Chulalongkorn Memorial Hospital | Patumwan | Bangkok |
Turkey | Acibadem Adana Hospital | Adana | |
Turkey | Adana Numune Training and Research Hospital | Adana | |
Turkey | Hacettepe University Medical Faculty | Ankara | |
Turkey | Akdeniz University Medical Faculty | Antalya | |
Turkey | Dicle University, Medical faculty | Diyarbakir | |
Turkey | Istanbul University Cerrahpasa Medical Faculty | Istanbul | |
Turkey | Marmara University Pendik Research and Training Hospital | Istanbul | |
Turkey | Kocaeli University Medical Faculty | Kocaeli | |
Turkey | Konya Necmettin Erbakan University Meram Medical Faculty | Konya | |
Turkey | Inonu Uni. Med. Fac. | Malatya | |
Turkey | Mersin University Medical Faculty | Mersin | |
United Kingdom | Ninewells Hospital | Dundee | Tayside Region |
United Kingdom | Royal Surrey County Hospital | Guildford | Surrey |
United Kingdom | St James's University Hospital | Leeds | West Yorkshire |
United Kingdom | Barts Hospital | London | Greater London |
United Kingdom | University College London Hospitals | London | Greater London |
United Kingdom | The Christie | Manchester | Greater Manchester |
United Kingdom | Mount Vernon Hospital | Northwood | Middlesex |
United Kingdom | Derriford Hospital | Torquay | Devon |
United Kingdom | The Clatterbridge Cancer Centre | Wirral | Merseyside |
United States | Comprehensive Blood & Cancer Center | Bakersfield | California |
United States | St. Luke's Hospital | Bethlehem | Pennsylvania |
United States | Cedar Rapids Oncology Project | Cedar Rapids | Iowa |
United States | TriHealth Hatton Institute | Cincinnati | Ohio |
United States | UC Health Clinical Trials Office | Cincinnati | Ohio |
United States | Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of Washington - Seattle Cancer Care Alliance | East Seattle | Washington |
United States | Virginia Crosson Cancer Center | Fullerton | California |
United States | Greenville Hospital System University Medical Center (ITOR) | Greenville | South Carolina |
United States | Oncology Consultants, P.A. | Houston | Texas |
United States | Franciscan St. Francis Health Cancer Center | Indianapolis | Indiana |
United States | Mount Sinai - PRIME | Jamaica | New York |
United States | Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | UCLA Medical Center | Los Angeles | California |
United States | Virginia Piper Cancer Institute | Minneapolis | Minnesota |
United States | Clinical Research Alliance, Inc | New York | New York |
United States | Norwalk Hospital | Norwalk | Connecticut |
United States | UF Health Cancer Center Orlando | Orlando | Florida |
United States | Oncology Specialists, S.C. | Park Ridge | Illinois |
United States | Memorial West Cancer Institute | Pembroke Pines | Florida |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California |
United States | University of Rochester | Rochester | New York |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Sansum Clinic | Santa Barbara | California |
United States | Trio - Central Coast Medical Oncology Corporation | Santa Maria | California |
United States | Northwest Medical Specialties, PLLC | Tacoma | Washington |
United States | University of South Florida - Parent | Tampa | Florida |
United States | Baylor Scott & White Health | Temple | Texas |
United States | Cotton-O'Neil Clinical Research Center, Hematology and Oncology | Topeka | Kansas |
United States | Wenatchee Valley Hospital & Clinics | Wenatchee | Washington |
United States | University of Kansas Medical Center Research Institute, Inc. | Westwood | Kansas |
Lead Sponsor | Collaborator |
---|---|
EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany |
United States, Australia, Brazil, Canada, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates. | From randomization into maintenance phase up to 1276 days | |
Secondary | Progression Free Survival (PFS) by Independent Review Committee (IRC) | The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. | From randomization into maintenance phase up to 1276 days | |
Secondary | Best Overall Response (BOR) by Investigator Assessment | BOR was determined by RECIST v1.1 per Investigator assessment and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD equal to progression <=2 weeks after date of randomization. | From randomization into maintenance phase up to 1276 days | |
Secondary | Objective Response Rate (ORR) by Investigator Assessment | The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. | From randomization into maintenance phase up to 1276 days | |
Secondary | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | |
Secondary | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | |
Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | |
Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) | |
Secondary | Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported. | From randomization into maintenance phase up to 1276 days | |
Secondary | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented. | From baseline up to 1276 days | |
Secondary | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator. | From randomization into maintenance phase up to 1276 days | |
Secondary | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported. | From randomization into maintenance phase up to 1276 days | |
Secondary | Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 | ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported. | From randomization into maintenance phase up to 1276 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 |