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

NCT ID: NCT01839500

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-25

Study Completion Date

2018-01-09

Brief Summary

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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

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Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Trastuzumab

Intervention Type DRUG

Trastuzumab administered in accordance with routine care practice.

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.

No interventions assigned to this group

Cohort III: HER2-Positive non-mGC

HER2-positive non-mGC participants will be included in this cohort.

No interventions assigned to this group

Cohort IV: HER2-Negative mGC

HER2-negative mGC participants will be included in this cohort.

No interventions assigned to this group

Cohort V: HER2-Negative non-mGC

HER2-negative non-mGC participants will be included in this cohort.

No interventions assigned to this group

Interventions

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Trastuzumab

Trastuzumab administered in accordance with routine care practice.

Intervention Type DRUG

Other Intervention Names

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Herceptin

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Anyang Tumor Hosptial

Anyang, , China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, , China

Site Status

Peking University First Hospital

Beijing, , China

Site Status

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

Beijing, , China

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

Beijing Union Hospital

Beijing, , China

Site Status

General Hospital of Chinese PLA; Department of Hematology

Beijing, , China

Site Status

the First Hospital of Jilin University

Changchun, , China

Site Status

Hu Nan Provincial Cancer Hospital

Changsha, , China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, , China

Site Status

Changzhou First People's Hospital

Changzhou, , China

Site Status

Sichuan Provincial Cancer Hospital

Chengdu, , China

Site Status

West China Hospital, Sichuan University

Chengdu, , China

Site Status

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status

Third Affiliated Hospital of Third Military Medical University

Chongqing, , China

Site Status

The First People's Hospital of Foshan

Foshan, , China

Site Status

Fujian Medical University Union Hospital

Fujian, , China

Site Status

The First Affiliated Hospital of Fujian Medical University

Fuzhou, , China

Site Status

Fujian Provincial Hospital

Fuzhou, , China

Site Status

Sun Yat-sen Memorial Hospital

Guangzhou, , China

Site Status

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, , China

Site Status

Nanfang Hospital, Southern Medical University

Guangzhou, , China

Site Status

Guizhou Provincial People's Hospital

Guiyang, , China

Site Status

Guizhou Cancer Hospital

Guiyang, , China

Site Status

Hainan provincial people's hospital

Haikou, , China

Site Status

Cancer Hospital of Hangzhou (Wushan District)

Hangzhou, , China

Site Status

Hangzhou First People's Hospital

Hangzhou, , China

Site Status

Harbin Medical University Cancer Hospital

Harbin, , China

Site Status

The First Affiliated Hospital of Anhui Medical University

Hefei, , China

Site Status

Inner Mongolia People's Hospital

Hohhot, , China

Site Status

Affiliated Hospital of Inner Mongolia Medical College

Hohhot, , China

Site Status

The First Affilliated Hospital of Kunming Medical College

Kunming, , China

Site Status

The First People's Hospital of Yunnan Province

Kunming, , China

Site Status

Yunnan Cancer Hospital

Kunming, , China

Site Status

The First Affiliated Hospital of Lanzhou University

Lanzhou, , China

Site Status

Gansu Cancer Hospital

Lanzhou, , China

Site Status

Taizhou Hospital of Zhejiang Province

Linhai, , China

Site Status

The First Affiliated Hospital of Henan UN of Science and Technology

Luoyang, , China

Site Status

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, , China

Site Status

The Second Affiliated Hospital to Nanchang University

Nanchang, , China

Site Status

Jiangxi Cancer Hospital; First department of abdominal surgery

Nanchang, , China

Site Status

Affiliated Hospital of North Sichuan Medical College

Nanchong, , China

Site Status

Nanjing 1st Hospital; Endocrinology Dept.

Nanjing, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Jiangsu Province Hospital

Nanjing, , China

Site Status

The 81st Hospital of P.L.A.

Nanjing, , China

Site Status

Affiliated Hospital of Nantong University

Nantong, , China

Site Status

Nan Tong Tumor Hospital

Nantong, , China

Site Status

The Affiliated Hospital of Medical College Qingdao University

Qingdao, , China

Site Status

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Changhai Hospital of Shanghai

Shanghai, , China

Site Status

Changhai Hospital; Oncology

Shanghai, , China

Site Status

Shaoxing People's Hospital

Shaoxing, , China

Site Status

Liaoning cancer Hospital & Institute

Shenyang, , China

Site Status

Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

Shijiazhuang, , China

Site Status

First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status

Shanxi Province Cancer Hospital

Taiyuan, , China

Site Status

Tianjin Medical University General Hospital

Tianjin (天津), , China

Site Status

The Tumor Hospital of Xinjiang Medical University

Ürümqi, , China

Site Status

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, , China

Site Status

The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College

Wenzhou, , China

Site Status

Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology

Wuhan, , China

Site Status

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

Wuhan, , China

Site Status

Zhongnan Hospital of Wuhan University

Wuhan, , China

Site Status

Hubei Cancer Hospital

Wuhan, , China

Site Status

Wuxi No.4 People's Hospital

Wuxi, , China

Site Status

The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

Xi'an, , China

Site Status

The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

Xi'an, , China

Site Status

Shanxi Provincial People's Hospital

Xi'an, , China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, , China

Site Status

Zhongshan Hospital Xiamen University

Xiamen, , China

Site Status

Xinxiang Central Hospital

Xinxiang, , China

Site Status

Northern Jangsu People's Hospital

Yangzhou, , China

Site Status

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, , China

Site Status

Henan Provincial People's Hospital

Zhengzhou, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status

Affiliated Hospital of Jiangsu University

Zhenjiang, , China

Site Status

Countries

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China

Other Identifiers

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ML28934

Identifier Type: -

Identifier Source: org_study_id

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