A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer

Gastric Cancer Clinical Trial

— EVIDENCE  

Official title:

A Non-Interventional, Registry Study for Chinese Gastric Cancer Patients With HER2 Status: Clinical and Pathological Characteristics, Treatment Patterns and Clinical Outcomes (EVIDENCE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839500
• Other study ID #: ML28934
• Status: Completed
• First received: April 22, 2013
• Last updated: March 28, 2018
• Start date: April 25, 2013
• Est. completion date: January 9, 2018

Study information

• Verified date: March 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: January 9, 2018
• Est. primary completion date: January 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

• Participants receiving regimen in a blinded trial

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Trastuzumab
Trastuzumab administered in accordance with routine care practice.

Locations

Country	Name	City	State
China	Anyang Tumor Hosptial	Anyang
China	Beijing Cancer Hospital	Beijing
China	Beijing Union Hospital	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences.	Beijing
China	General Hospital of Chinese PLA; Department of Hematology	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)	Beijing
China	the First Hospital of Jilin University	Changchun
China	Hu Nan Provincial Cancer Hospital	Changsha
China	The Second Xiangya Hospital of Central South University	Changsha
China	Changzhou First People's Hospital	Changzhou
China	Sichuan Provincial Cancer Hospital	Chengdu
China	Sichuan Provincial People's Hospital	Chengdu
China	West China Hospital, Sichuan University	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	Sun Yat-sen Memorial Hospital	Guangzhou
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou
China	Guizhou Cancer Hospital	Guiyang
China	Guizhou Provincial People's Hospital	Guiyang
China	Hainan provincial people's hospital	Haikou
China	Cancer Hospital of Hangzhou (Wushan District)	Hangzhou
China	Hangzhou First People's Hospital	Hangzhou
China	Harbin Medical University Cancer Hospital	Harbin
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 Affilliated Hospital of Kunming Medical College	Kunming
China	The First People's Hospital of Yunnan Province	Kunming
China	Yunnan Cancer Hospital	Kunming
China	Gansu Cancer Hospital	Lanzhou
China	The First Affiliated Hospital of Lanzhou University	Lanzhou
China	Taizhou Hospital of Zhejiang Province	Linhai
China	The First Affiliated Hospital of Henan UN of Science and Technology	Luoyang
China	Jiangxi Cancer Hospital; First department of abdominal surgery	Nanchang
China	The 1st Affiliated Hospital of Nanchang Unversity	Nanchang
China	The Second Affiliated Hospital to Nanchang University	Nanchang
China	Affiliated Hospital of North Sichuan Medical College	Nanchong
China	Jiangsu Cancer Hospital	Nanjing
China	Jiangsu Province Hospital	Nanjing
China	Nanjing 1st Hospital; Endocrinology Dept.	Nanjing
China	The 81st Hospital of P.L.A.	Nanjing
China	Affiliated Hospital of Nantong University	Nantong
China	Nan Tong Tumor Hospital	Nantong
China	The Affiliated Hospital of Medical College Qingdao University	Qingdao
China	Changhai Hospital of Shanghai	Shanghai
China	Changhai Hospital; Oncology	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai
China	Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shaoxing People's Hospital	Shaoxing
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 (??)
China	The First Teaching Hospital of Xinjiang Medical University	Urumqi
China	The Tumor Hospital of Xinjiang Medical University	Urumqi
China	The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College	Wenzhou
China	Hubei Cancer Hospital	Wuhan
China	Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech	Wuhan
China	Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology	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	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	Henan Provincial People's Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Affiliated Hospital of Jiangsu University	Zhenjiang

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Baseline up to death (up to approximately 5 years)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events		Baseline up to approximately 5 years
Secondary	Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments)		Baseline up to approximately 5 years
Secondary	Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline		Baseline up to first follow-up (up to approximately 5 years)
Secondary	Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons		Baseline up to first follow-up (up to approximately 5 years)