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A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

NCT02563054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2016-11-02

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.

Conditions

Interventions

DRUG

5-Fluorouracil

Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m\^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

DRUG

Capecitabine

Participants will receive oral capecitabine, 1000 mg/m\^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

DRUG

Cisplatin

Participants will receive cisplastin, 80 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Argentina
  • Belize
  • Brazil
  • China
  • Colombia
  • Guatemala
  • Hong Kong
  • Malaysia
  • Mexico
  • Panama
  • Peru
  • Russia
  • South Korea
  • Uruguay

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563054 on ClinicalTrials.gov