A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer
- Registration Number
- NCT01839500
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective, multi-center, non-interventional study will evaluate the efficacy and safety of trastuzumab in routine clinical practice in Chinese participants with gastric or gastro-oesophageal cancer. The study will be conducted in 5 cohorts and eligible participants will be enrolled and assigned to the various cohorts according to human epidermal growth factor receptor 2 (HER2) status, disease stage and treatment with trastuzumab according to physician's decision. Treatment patterns and clinical outcomes in participants with gastric cancer in China will be evaluated. The total study duration is 60 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
General Inclusion Criteria:
- Histologically confirmed cancer of the stomach or gastro-oesophageal junction or recurrent disease within 6 months before the date of recruitment
- Documented participant with trackable medical records
- HER2 status by immunohistochemistry (IHC) is known
Specific Inclusion Criteria:
- Cohort I/II/IV: Participants with mGC: with recurrent or metastatic disease or with inoperable locally advanced disease
- Cohort III/V: Participants with operable non-mGC: TxNxM0 (according to American Joint Committee on Cancer [AJCC] edition 7th)
- Participants receiving regimen in a blinded trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort I: HER2-Positive mGC Treated With Trastuzumab Trastuzumab HER2-positive metastatic gastric cancer (mGC) participants who are treated with trastuzumab will be included in this cohort. As this is an observational study, treatment schedule will be at the clinician's discretion in accordance with routine care practice and not dictated by the protocol.
- Primary Outcome Measures
Name Time Method Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) Overall Survival Baseline up to death (up to approximately 5 years) Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria Baseline up to disease recurrence or progression or death, whichever occurs first (up to approximately 5 years) Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) Criteria Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) Cohort I, II, IV: Time to Treatment Failure (TTF), as Assessed by the Investigator Using RECIST V1.1 Criteria Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) Cohort III, V: Disease-Free Survival (DFS), as Assessed by the Investigator Using RECIST V1.1 Criteria Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
- Secondary Outcome Measures
Name Time Method Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events Baseline up to approximately 5 years Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments) Baseline up to approximately 5 years Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons Baseline up to first follow-up (up to approximately 5 years) Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline Baseline up to first follow-up (up to approximately 5 years)
Trial Locations
- Locations (81)
Anyang Tumor Hosptial
🇨🇳Anyang, China
Cancer Hospital Chinese Academy of Medical Sciences.
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
🇨🇳Beijing, China
Beijing Union Hospital
🇨🇳Beijing, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Hu Nan Provincial Cancer Hospital
🇨🇳Changsha, China
General Hospital of Chinese PLA; Department of Hematology
🇨🇳Beijing, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, China
Changzhou First People's Hospital
🇨🇳Changzhou, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Third Affiliated Hospital of Third Military Medical University
🇨🇳ChongQing, China
The First People's Hospital of Foshan
🇨🇳Foshan, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fu Zhou, China
Fujian Medical University Union Hospital
🇨🇳Fujian, China
Fujian Provincial Hospital
🇨🇳Fuzhou, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, China
Guizhou Cancer Hospital
🇨🇳Guiyang, China
Hainan provincial people's hospital
🇨🇳Haikou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Cancer Hospital of Hangzhou (Wushan District)
🇨🇳Hangzhou, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
Affiliated Hospital of Inner Mongolia Medical College
🇨🇳Hohhot, China
Inner Mongolia People's Hospital
🇨🇳Hohhot, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, China
Taizhou Hospital of Zhejiang Province
🇨🇳Linhai, China
Yunnan Cancer Hospital
🇨🇳Kunming, China
The First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, China
Gansu Cancer Hospital
🇨🇳Lanzhou, China
The 1st Affiliated Hospital of Nanchang Unversity
🇨🇳Nanchang, China
The First Affiliated Hospital of Henan UN of Science and Technology
🇨🇳Luoyang, China
The Second Affiliated Hospital to Nanchang University
🇨🇳Nanchang, China
Jiangxi Cancer Hospital; First department of abdominal surgery
🇨🇳Nanchang, China
Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, China
Nan Tong Tumor Hospital
🇨🇳Nantong, China
The Affiliated Hospital of Medical College Qingdao University
🇨🇳Qingdao, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, China
Shaoxing People's Hospital
🇨🇳Shaoxing, China
Changhai Hospital; Oncology
🇨🇳Shanghai, China
Liaoning cancer Hospital & Institute
🇨🇳Shenyang, China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
🇨🇳Shijiazhuang, China
First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Shanxi Province Cancer Hospital
🇨🇳Taiyuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin (天津), China
The Tumor Hospital of Xinjiang Medical University
🇨🇳Urumqi, China
Hubei Cancer Hospital
🇨🇳Wuhan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, China
Sichuan Provincial Cancer Hospital
🇨🇳Chengdu, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, China
The First Affilliated Hospital of Kunming Medical College
🇨🇳Kunming, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
The First Teaching Hospital of Xinjiang Medical University
🇨🇳Urumqi, China
The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College
🇨🇳Wenzhou, China
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
🇨🇳Wuhan, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
🇨🇳Wuhan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, China
Wuxi No.4 People's Hospital
🇨🇳Wuxi, China
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
🇨🇳Xi'an, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
🇨🇳Xi'an, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
The 81st Hospital of P.L.A.
🇨🇳Nanjing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, China
Shanxi Provincial People's Hospital
🇨🇳Xian, China
Xinxiang Central Hospital
🇨🇳Xinxiang, China
Northern Jangsu People's Hospital
🇨🇳Yangzhou, China
Zhangzhou Municipal Hospital of Fujian Province
🇨🇳Zhangzhou, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Nanjing 1st Hospital; Endocrinology Dept.
🇨🇳Nanjing, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China