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

Roche

Status

Completed

Conditions

Gastric Cancer

Treatments

Drug: Trastuzumab

Study type

Observational

Funder types

Industry

Identifiers

NCT01839500

ML28934

Details and patient eligibility

About

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.

Enrollment

1,600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,600 participants in 5 patient groups

Cohort I: HER2-Positive mGC Treated With Trastuzumab

Description:

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.

Treatment:

Drug: Trastuzumab

Cohort II: HER2-Positive mGC not Treated With Trastuzumab

Description:

HER2-positive mGC participants who are not treated with trastuzumab will be included in this cohort.

Cohort III: HER2-Positive non-mGC

Description:

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

Cohort IV: HER2-Negative mGC

Description:

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

Cohort V: HER2-Negative non-mGC