NCT02274376

Brief Summary

This observational study will collect prospective data on the safety and tolerability of Xeloda in patients with advanced gastric cancer from every day clinical practice. Documentation of treatment for each patient is to continue until the end of treatment per oncologist's assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

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

August 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4.3 years

First QC Date

October 3, 2014

Last Update Submit

November 1, 2016

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    Up to 4 years

  • Safety and tolerability: incidence and nature of adverse drug reactions

    Up to 4 years

Secondary Outcomes (4)

  • Proportion of patients with modifications in Xeloda dosing

    Up to 4 years

  • Average duration of treatment

    Up to 4 years

  • Number of modifications in chosen regimen combination therapy

    Up to 4 years

  • Incidence and nature of dose interruptions

    Up to 4 years

Study Arms (1)

Cohort

Eligibility Criteria

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

Patients with advanced gastric cancer eligible for Xeloda (capecitabine)

You may qualify if:

  • Patients aged \>/=18 years, with metastatic gastric cancer who are available for prospective documentation of their treatment (first-line chemotherapy)
  • Informed consent

You may not qualify if:

  • Contraindications to Xeloda per the Summary of Product Characteristics (SmPC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 24, 2014

Study Start

August 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(1)