NCT02305043

Brief Summary

The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
549

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

3.8 years

First QC Date

November 17, 2014

Last Update Submit

July 10, 2018

Conditions

Esophageal NeoplasmsStomach Neoplasms

Keywords

non-interventionaladvanced gastric cancerTrastuzumabHER2

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Objective Response

    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimension of the target lesion

    12 months

Secondary Outcomes (2)

  • time-to-progression

    up to 24 months

  • overall survival

    up to 24 months

Interventions

non-interventionalOTHER

non-interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients suffer from histologically proven adenocarcinoma of the stomach or gastroesophageal junction

You may qualify if:

  • histologically proven adenocarcinoma of the stomach or gastroesophageal junction
  • stage IV
  • patient receives chemotherapy
  • signed informed consent
  • Age \> 18 years

You may not qualify if:

  • Patient can not understand meaning and purpose of the study
  • patient already received a chemotherapy treatment for advanced disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Cancer Center Leipzig

Leipzig, 04103, Germany

Location

Related Publications (3)

  • Wang J, Sun N, Kunzke T, Shen J, Feuchtinger A, Wang Q, Meixner R, Gleut RL, Haffner I, Luber B, Lordick F, Walch A. Metabolic heterogeneity affects trastuzumab response and survival in HER2-positive advanced gastric cancer. Br J Cancer. 2024 Apr;130(6):1036-1045. doi: 10.1038/s41416-023-02559-6. Epub 2024 Jan 24.

    PMID: 38267634DERIVED

  • Ebert K, Haffner I, Zwingenberger G, Keller S, Raimundez E, Geffers R, Wirtz R, Barbaria E, Hollerieth V, Arnold R, Walch A, Hasenauer J, Maier D, Lordick F, Luber B. Combining gene expression analysis of gastric cancer cell lines and tumor specimens to identify biomarkers for anti-HER therapies-the role of HAS2, SHB and HBEGF. BMC Cancer. 2022 Mar 9;22(1):254. doi: 10.1186/s12885-022-09335-4.

    PMID: 35264144DERIVED

  • Haffner I, Schierle K, Raimundez E, Geier B, Maier D, Hasenauer J, Luber B, Walch A, Kolbe K, Riera Knorrenschild J, Kretzschmar A, Rau B, Fischer von Weikersthal L, Ahlborn M, Siegler G, Fuxius S, Decker T, Wittekind C, Lordick F. HER2 Expression, Test Deviations, and Their Impact on Survival in Metastatic Gastric Cancer: Results From the Prospective Multicenter VARIANZ Study. J Clin Oncol. 2021 May 1;39(13):1468-1478. doi: 10.1200/JCO.20.02761. Epub 2021 Mar 25.

    PMID: 33764808DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Florian Lordick, Prof.

    University Cancer Center Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director University Cancer Center Leipzig

Study Record Dates

First Submitted

November 17, 2014

First Posted

December 2, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 31, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

DE(1)