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Completed

NCT Number: NCT01839500

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anyang Tumor Hosptial, Anyang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

Trastuzumab administered in accordance with routine care practice.

Other names: Herceptin

Primary outcomes

  1. Overall Survival

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

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

    Time frame: Baseline up to approximately 5 years

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

    Time frame: Baseline up to approximately 5 years

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Non-Interventional, Registry Study for Chinese Gastric Cancer Patients With HER2 Status: Clinical and Pathological Characteristics, Treatment Patterns and Clinical Outcomes (EVIDENCE)

Acronym: EVIDENCE

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2013
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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