Trials Sponsors Conditions Drugs Pricing

Conditions

Gastric Carcinoma Stage IV

Outcome Measures

Primary Outcomes (1)

Progression free survival
6 months after treatment

Secondary Outcomes (3)

Response rate
every 6 weeks up to 6 months
overall survival
3 years later initial study start
performance status (quality of life)
Every 6 weeks up to 1 year

Study Arms (2)

XELOX

EXPERIMENTAL

Capecitabine 1000mg/m2 bid D1-D14 Oxaliplatin 130mg/m2 + 5% Dextrose water (5DW) 500ml over 2hour D1 Q 2weeks

Drug: XELOX

FOLFOX

ACTIVE COMPARATOR

Oxaliplatin 85mg/m2 + 5DW 500ml over 2hr D1 Leucovorin 400mg/m2 + 5DW 500ml over 2hr D1 5-Fluorouracil (5-FU) 400mg/m2 IV PUSH D1 5-FU 1200mg/m2 + 5DW 1 Liter over 22hr D1-D2 Q 2weeks

Drug: FOLFOX

Interventions

XELOXDrug

capecitabine 1000mg/m2 bid po D1-D14

Also known as: Xeloda

XELOX

FOLFOXDrug

5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2

Also known as: 5-FU

FOLFOX

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age :older than 20
A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period). (RECIST v1.1)

Sponsors & Collaborators

Dong-A University Hospital
Otherlead

Study Sites (1)

Dong-A University Hospital

Busan, 602-715, South Korea

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

XELOXCapecitabineFolfox protocolFluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine

Study Officials

Sung Yong Oh, M.D.
Dong-A University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

December 9, 2012

First Posted

December 13, 2012

Study Start

December 2012

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

XELOX

FOLFOX

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

XELOX

FOLFOX

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations