A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer
- Registration Number
- NCT01839500
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
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)
- Participants receiving regimen in a blinded trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort I: HER2-Positive mGC Treated With Trastuzumab 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.
- Primary Outcome Measures
Name Time Method Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) Overall Survival Baseline up to death (up to approximately 5 years) Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria Baseline up to disease recurrence or progression or death, whichever occurs first (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 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 Baseline up to disease 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 Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
- Secondary Outcome Measures
Name Time Method Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events Baseline up to approximately 5 years Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments) Baseline up to approximately 5 years Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline Baseline up to first follow-up (up to approximately 5 years) Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons Baseline up to first follow-up (up to approximately 5 years)
Trial Locations
- Locations (81)
Anyang Tumor Hosptial
🇨🇳Anyang, China
Cancer Hospital Chinese Academy of Medical Sciences.
🇨🇳Beijing, China
Peking University First Hospital
🇨🇳Beijing, China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Beijing Union Hospital
🇨🇳Beijing, China
General Hospital of Chinese PLA; Department of Hematology
🇨🇳Beijing, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Hu Nan Provincial Cancer Hospital
🇨🇳Changsha, China
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