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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01839500
First received: April 22, 2013
Last updated: May 17, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Gastric Cancer
Drug: Trastuzumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Secondary Outcome Measures:
  • Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events [ Time Frame: 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 ]
  • 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) ]
  • 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) ]

Estimated Enrollment: 1600
Actual Study Start Date: April 25, 2013
Estimated Study Completion Date: November 21, 2017
Estimated Primary Completion Date: November 21, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with gastric or gastro-oesophageal junction cancers in China
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839500

  Show 81 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01839500     History of Changes
Other Study ID Numbers: ML28934
Study First Received: April 22, 2013
Last Updated: May 17, 2017

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017