Trial record 11 of 456 for:    Open Studies | "Stomach Diseases"

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

This study is currently recruiting participants.
Verified April 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: April 14, 2014
Last verified: April 2014
  Purpose

This prospective, multi-center, non-interventional study will evaluate the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in Chinese patients with gastric or gastro-oesophageal cancer. Treatment patterns and clinical 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: 3500
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
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 63 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: April 14, 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 April 15, 2014