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

March 28, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Anyang, China
        • Anyang Tumor Hosptial
      • Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences.
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100730
        • Beijing Union Hospital
      • Beijing, China, 100083
        • Peking University Third Hospital
      • Beijing, China, 100071
        • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100853
        • General Hospital of Chinese PLA; Department of Hematology
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Changsha, China, 410006
        • Hu Nan Provincial Cancer Hospital
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South University
      • Changzhou, China, 213003
        • Changzhou First People's Hospital
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, China, 610041
        • Sichuan Provincial Cancer Hospital
      • Chengdu, China, 610072
        • Sichuan Provincial People's Hospital
      • ChongQing, China, 400042
        • Third Affiliated Hospital of Third Military Medical University
      • Foshan, China, 510000
        • The First People's Hospital of Foshan
      • Fu Zhou, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University
      • Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, China
        • Fujian Provincial Hospital
      • Guangzhou, China, 510000
        • Sun Yat-sen Memorial Hospital
      • Guangzhou, China, 510515
        • Nanfang Hospital, Southern Medical University
      • Guangzhou, China, 510080
        • The First Affiliated Hospital, Sun Yat-Sen University
      • Guiyang, China, 550002
        • Guizhou Provincial People's Hospital
      • Guiyang, China, 550004
        • Guizhou Cancer Hospital
      • Haikou, China, 570311
        • Hainan Provincial People's Hospital
      • Hangzhou, China, 310002
        • Cancer Hospital of Hangzhou (Wushan District)
      • Hangzhou, China, 310006
        • Hangzhou First People's Hospital
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Hefei, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hohhot, China, 010050
        • Affiliated Hospital of Inner Mongolia Medical College
      • Hohhot, China, 010017
        • Inner Mongolia People's Hospital
      • Kunming, China, 650032
        • The First Affilliated Hospital of Kunming Medical College
      • Kunming, China, 650118
        • Yunnan Cancer Hospital
      • Kunming, China, 650032
        • The First People's Hospital of Yunnan Province
      • Lanzhou, China, 730000
        • The First Affiliated Hospital of Lanzhou University
      • Lanzhou, China, 730050
        • Gansu Cancer Hospital
      • Linhai, China, 317000
        • Taizhou Hospital of Zhejiang Province
      • Luoyang, China, 471003
        • The First Affiliated Hospital of Henan UN of Science and Technology
      • Nanchang, China, 330006
        • The Second Affiliated Hospital to Nanchang University
      • Nanchang, China, 330006
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Nanchang, China, 330029
        • Jiangxi Cancer Hospital; First department of abdominal surgery
      • Nanchong, China
        • Affiliated Hospital of North Sichuan Medical College
      • Nanjing, China, 210036
        • Jiangsu Province Hospital
      • Nanjing, China, 210009
        • Jiangsu Cancer Hospital
      • Nanjing, China
        • The 81st Hospital of P.L.A.
      • Nanjing, China, 210006
        • Nanjing 1st Hospital; Endocrinology Dept.
      • Nantong, China, 226001
        • Affiliated Hospital of Nantong University
      • Nantong, China
        • Nan Tong Tumor Hospital
      • Qingdao, China, 266003
        • The Affiliated Hospital of Medical College Qingdao University
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200025
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Shanghai, China, 200433
        • Changhai Hospital of Shanghai
      • Shanghai, China, 200127
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, China, 200433
        • Changhai Hospital; Oncology
      • Shaoxing, China, 312000
        • Shaoxing People's Hospital
      • Shenyang, China, 110042
        • Liaoning Cancer Hospital & Institute
      • Shijiazhuang, China, 050035
        • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
      • Suzhou, China, 215006
        • First Affiliated Hospital of Soochow University
      • Taiyuan, China
        • Shanxi Province Cancer Hospital
      • Tianjin (天津), China, 300052
        • Tianjin Medical University General Hospital
      • Urumqi, China, 830054
        • The First Teaching Hospital of Xinjiang Medical University
      • Urumqi, China, 830000
        • The Tumor Hospital of Xinjiang Medical University
      • Wenzhou, China, 325000
        • The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College
      • Wuhan, China, 430030
        • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
      • Wuhan, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, China, 430022
        • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
      • Wuhan, China, 430071
        • Zhongnan Hospital of Wuhan University
      • Wuxi, China, 310000
        • Wuxi No.4 People's Hospital
      • Xi'an, China, 710038
        • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
      • Xi'an, China, 710032
        • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
      • Xiamen, China, 361003
        • The First Affiliated Hospital of Xiamen University
      • Xiamen, China, 361004
        • Zhongshan Hospital Xiamen University
      • Xian, China, 710068
        • Shanxi Provincial People's Hospital
      • Xinxiang, China
        • Xinxiang Central Hospital
      • Yangzhou, China
        • Northern Jangsu People's Hospital
      • Zhangzhou, China, 363000
        • Zhangzhou Municipal Hospital of Fujian Province
      • Zhengzhou, China, 450003
        • Henan Provincial People's Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
      • Zhengzhou, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhenjiang, China, 212001
        • Affiliated Hospital of Jiangsu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with gastric or gastro-oesophageal junction cancers in China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort I: HER2-Positive mGC Treated With 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.
Drug: Trastuzumab
Trastuzumab administered in accordance with routine care practice.
Other Names:
  • Herceptin
Cohort II: HER2-Positive mGC not Treated With Trastuzumab
HER2-positive mGC participants who are not treated with trastuzumab will be included in this cohort.
Cohort III: HER2-Positive non-mGC
HER2-positive non-mGC participants will be included in this cohort.
Cohort IV: HER2-Negative mGC
HER2-negative mGC participants will be included in this cohort.
Cohort V: HER2-Negative non-mGC
HER2-negative non-mGC participants will be included in this cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Baseline up to death (up to approximately 5 years)
Baseline up to death (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
Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
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
Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
Time Frame: Baseline up to disease recurrence or progression or death, whichever occurs first (up to approximately 5 years)
Baseline up to disease recurrence or 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
Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2013

Primary Completion (ACTUAL)

January 9, 2018

Study Completion (ACTUAL)

January 9, 2018

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (ESTIMATE)

April 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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