NCT02063412

Brief Summary

The objective of this study is to compare the possible time savings from reduction of nursing and pharmacy time to manage AEGC patients using capecitabine-based regimens versus traditional intravenous chemotherapy in the Hong Kong public hospital setting.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Status
withdrawn

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, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

February 13, 2014

Last Update Submit

February 1, 2017

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Composite preparation, dispensing, and administration time

    This is a time-and-motion study conducted in 2 public hospitals of Hong Kong based on the simulation of previously data on both capecitabine-based regimen (XELOX and XP) and IV 5-FU-based regimen (FOLFOX and FP)

    Up to 6 months after initiation of chemotherapy

Study Arms (4)

XELOX

Capecitabine (Xeloda) 1000mg/m2 po bid x 14 days Oxaliplatin (Eloxatin) 130mg/m2 iv over 2 hrs d1 Q3w x 8 cycles

XP

Cisplatin (CDDP) 80 mg/m2 iv over 3 hrs d1 Capecitabine (Xeloda) 1000 mg/m2 po bid d1-14, Q3w

FOLFOX

Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and d2 5-FU 400mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d1 and d2 Q2w

FP

Cisplatin (CDDP) 100 mg/m2 iv d1 5-FU 1000 mg/m2/d civi d1-5, Q4w

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who were diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4-based chemotherapy treatment

You may qualify if:

  • Aged 18 or above
  • Diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4- based chemotherapy treatment

You may not qualify if:

  • Persons \< 18 years of age;
  • Pregnant or lactating women;
  • Persons related unequally to investigators (e.g. student, employee);
  • Special population (e.g. prisoner, mentally, congnitively disabled);
  • Patients who refused to sign consent or not willing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Vivian WY Lee, PharmD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 2, 2017

Record last verified: 2017-02