Clinical trial NCT01839500: A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with gastric or gastro-oesophageal junction cancers in China

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: Baseline up to death (up to approximately 5 years)
measure: 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
timeFrame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
measure: Cohort I, II, IV: Time to Treatment Failure (TTF), as Assessed by the Investigator Using RECIST V1.1 Criteria
timeFrame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
measure: Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
timeFrame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
measure: Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
timeFrame: Baseline up to disease recurrence or progression or death, whichever occurs first (up to approximately 5 years)
measure: Cohort III, V: Disease-Free Survival (DFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
timeFrame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Secondary outcomes:
measure: Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events
timeFrame: Baseline up to approximately 5 years
measure: Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments)
timeFrame: Baseline up to approximately 5 years
measure: Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline
timeFrame: Baseline up to first follow-up (up to approximately 5 years)
measure: Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons
timeFrame: Baseline up to first follow-up (up to approximately 5 years)
Other outcomes:
Locations:
city: Anyang
country: China
facility: Anyang Tumor Hosptial
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Union Hospital
city: Beijing
country: China
facility: General Hospital of Chinese PLA; Department of Hematology
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changsha
country: China
facility: Hu Nan Provincial Cancer Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changzhou
country: China
facility: Changzhou First People's Hospital
city: Chengdu
country: China
facility: Sichuan Provincial Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: ChongQing
country: China
facility: Third Affiliated Hospital of Third Military Medical University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Fu Zhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Fujian
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
city: Haikou
country: China
facility: Hainan provincial people's hospital
city: Hangzhou
country: China
facility: Cancer Hospital of Hangzhou (Wushan District)
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical College
city: Kunming
country: China
facility: The First Affilliated Hospital of Kunming Medical College
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Lanzhou
country: China
facility: The First Affiliated Hospital of Lanzhou University
city: Lanzhou
country: China
facility: Gansu Cancer Hospital
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan UN of Science and Technology
city: Nanchang
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital; First department of abdominal surgery
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
city: Nanjing
country: China
facility: Nanjing 1st Hospital; Endocrinology Dept.
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: The 81st Hospital of P.L.A.
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Nantong
country: China
facility: Nan Tong Tumor Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
city: Shanghai
country: China
facility: Changhai Hospital; Oncology
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
city: Shenyang
country: China
facility: Liaoning cancer Hospital & Institute
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
city: Tianjin (天津)
country: China
facility: Tianjin Medical University General Hospital
city: Urumqi
country: China
facility: The Tumor Hospital of Xinjiang Medical University
city: Urumqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
city: Wenzhou
country: China
facility: The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College
city: Wuhan
country: China
facility: Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
city: Wuhan
country: China
facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuxi
country: China
facility: Wuxi No.4 People's Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
city: Xi'an
country: China
facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
city: Xian
country: China
facility: Shanxi Provincial People's Hospital
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
city: Yangzhou
country: China
facility: Northern Jangsu People's Hospital
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: