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Gastric CancerEVIDENCENCT01839500

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

An observational study of Gastric Cancer, run by Hoffmann-La Roche at 81 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Trastuzumab
How many people
1,600 participants
Where
81 sitesChina
Study dates
25 Apr 2013to 9 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with gastric or gastro-oesophageal junction cancers in China

Who may be able to join

  • 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)

Who cannot join

  • Participants receiving regimen in a blinded trial

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

China81 sites

  • Anyang Tumor Hosptial

    Anyang

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

  • Peking University First Hospital

    Beijing, 100034

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

    Beijing, 100071

  • Peking University Third Hospital

    Beijing, 100083

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Union Hospital

    Beijing, 100730

  • General Hospital of Chinese PLA; Department of Hematology

    Beijing, 100853

  • the First Hospital of Jilin University

    Changchun, 130021

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • Changzhou First People's Hospital

    Changzhou, 213003

  • Sichuan Provincial Cancer Hospital

    Chengdu, 610041

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Third Affiliated Hospital of Third Military Medical University

    Chongqing, 400042

  • The First People's Hospital of Foshan

    Foshan, 510000

  • Fujian Medical University Union Hospital

    Fujian, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

  • Fujian Provincial Hospital

    Fuzhou

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510000

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • Guizhou Provincial People's Hospital

    Guiyang, 550002

  • Guizhou Cancer Hospital

    Guiyang, 550004

  • Hainan provincial people's hospital

    Haikou, 570311

  • Cancer Hospital of Hangzhou (Wushan District)

    Hangzhou, 310002

  • Hangzhou First People's Hospital

    Hangzhou, 310006

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Inner Mongolia People's Hospital

    Hohhot, 010017

  • Affiliated Hospital of Inner Mongolia Medical College

    Hohhot, 010050

  • The First Affilliated Hospital of Kunming Medical College

    Kunming, 650032

  • The First People's Hospital of Yunnan Province

    Kunming, 650032

  • Yunnan Cancer Hospital

    Kunming, 650118

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, 730000

  • Gansu Cancer Hospital

    Lanzhou, 730050

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000

  • The First Affiliated Hospital of Henan UN of Science and Technology

    Luoyang, 471003

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006

  • The Second Affiliated Hospital to Nanchang University

    Nanchang, 330006

  • Jiangxi Cancer Hospital; First department of abdominal surgery

    Nanchang, 330029

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong

  • Nanjing 1st Hospital; Endocrinology Dept.

    Nanjing, 210006

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Jiangsu Province Hospital

    Nanjing, 210036

  • The 81st Hospital of P.L.A.

    Nanjing

  • Affiliated Hospital of Nantong University

    Nantong, 226001

  • Nan Tong Tumor Hospital

    Nantong

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266003

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

  • Changhai Hospital of Shanghai

    Shanghai, 200433

  • Changhai Hospital; Oncology

    Shanghai, 200433

  • Shaoxing People's Hospital

    Shaoxing, 312000

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042

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

    Shijiazhuang, 050035

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Shanxi Province Cancer Hospital

    Taiyuan

  • Tianjin Medical University General Hospital

    Tianjin (天津), 300052

  • The Tumor Hospital of Xinjiang Medical University

    Ürümqi, 830000

  • The First Teaching Hospital of Xinjiang Medical University

    Ürümqi, 830054

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

    Wenzhou, 325000

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

    Wuhan, 430022

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

    Wuhan, 430030

  • Zhongnan Hospital of Wuhan University

    Wuhan, 430071

  • Hubei Cancer Hospital

    Wuhan, 430079

  • Wuxi No.4 People's Hospital

    Wuxi, 310000

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

    Xi'an, 710032

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

    Xi'an, 710038

  • Shanxi Provincial People's Hospital

    Xi'an, 710068

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004

  • Xinxiang Central Hospital

    Xinxiang

  • Northern Jangsu People's Hospital

    Yangzhou

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, 363000

  • Henan Provincial People's Hospital

    Zhengzhou, 450003

  • Henan Cancer Hospital

    Zhengzhou, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212001

Other trials in China

About this study

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)

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.

Conditions
Gastric Cancer
Being tested
Trastuzumab
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab administered in accordance with routine care practice.

Study groups in NCT01839500
Study groupRoleWhat they receive
Cohort I: HER2-Positive mGC Treated With TrastuzumabHER2-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.
Receives: Drug: Trastuzumab
Cohort II: HER2-Positive mGC not Treated With TrastuzumabHER2-positive mGC participants who are not treated with trastuzumab will be included in this cohort.
Cohort III: HER2-Positive non-mGCHER2-positive non-mGC participants will be included in this cohort.
Cohort IV: HER2-Negative mGCHER2-negative mGC participants will be included in this cohort.
Cohort V: HER2-Negative non-mGCHER2-negative non-mGC participants will be included in this cohort.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: Baseline up to death (up to approximately 5 years)

  2. 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

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

  3. Cohort I, II, IV: Time to Treatment Failure (TTF), as Assessed by the Investigator Using RECIST V1.1 Criteria

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

  4. Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

  5. Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria

    Measured: Baseline up to disease recurrence or progression or death, whichever occurs first (up to approximately 5 years)

  6. Cohort III, V: Disease-Free Survival (DFS), as Assessed by the Investigator Using RECIST V1.1 Criteria

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

Secondary outcomes (4)

  1. Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events

    Measured: Baseline up to approximately 5 years

  2. Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments)

    Measured: Baseline up to approximately 5 years

  3. Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline

    Measured: Baseline up to first follow-up (up to approximately 5 years)

  4. Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons

    Measured: Baseline up to first follow-up (up to approximately 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study start25 Apr 2013
  3. Primary completion9 Jan 2018
  4. Study completion9 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839500
Sponsor's protocol ID
ML28934
Acronym
EVIDENCE
Status last verified
Mar 2018
First submitted
22 Apr 2013
Last updated
29 Mar 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer, run by Hoffmann-La Roche at 81 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Baseline up to death (up to approximately 5 years)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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