EVIDENCE: A Non-Interventional Study of Treatment and Clinical Outcomes in Chinese Patients With Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01839500
First received: April 22, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This prospective, multi-center, non-interventional study will evaluate the effic acy and safety of Herceptin (trastuzumab) in routine clinical practice in Chines e patients with gastric or gastro-oesophageal cancer. Treatment patterns and cli nical outcomes in patients with gastric cancer in China will be evaluated. Data will be collected from eligible patients for up to 6 years.


Condition
Gastric Cancer

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival, defined as time from date of diagnosis of gastric cancer to death of any cause [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Response rate (RR), defined as proportion of patients with complete response (CR) or partial response (PR) based on their best overall response assessed by investigator [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Cohort I/II/IV: Time to treatment failure (TTF), defined as time from start of treatment in each line (1st, 2nd, 3rd line) to investigator-assessed disease progression in each line, or death of any cause [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Cohort I/II/V Progression-free survival (PFS) defined as time from treatment in each line (1st, 2nd, 3rd line) to investigator assessed progression or death from any cause [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Cohort III/V: Event-free survival (EFS), defined as time from date of diagnosis of gastric cancer to disease recurrence or progression, or death from any cause [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Cohort III/V: Disease-free survival (DFS), defined as time from R0 resection to investigator-assessed disease progression, or death of any cause [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events in patients receiving Herceptin [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Treatment regimens (drugs, dosage, duration) in routine clinical practice [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2600
Study Start Date: November 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort I: HER2-positive mGC treated with Herceptin
Cohort II: HER2-positive mGC not treated with Herceptin
Cohort III: HER2-positive non-mGC
Cohort IV: HER2-negative mGC
Cohort V: HER2-negative non-mGC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with gastric or gastro-oesophageal junction cancer

Criteria

Inclusion Criteria:

  • Histologically confirmed cancer of the stomach or gastro-oesophageal junction or recurrent disease within 6 months before the date of recruitment
  • Documented patient with trackable medical records
  • HER2 IHC status is known
  • Cohort I/II/IV:

Patients with mGC: with recurrent or metastatic disease or with inoperable locally advanced disease

  • Cohort III/V:

Patients with operable non-mGC: TxNxM0 (according to AJCC edition 7th)

Exclusion Criteria:

  • Patients 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

Contacts
Contact: Reference Study ID Number: ML28934 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 77 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: August 19, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014