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Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer

NCT01283204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-01-29

No results posted yet for this study

Summary

This study is to evaluate the antitumor activity (i.e. progression free survival, overall survival, response rate, etc), safety and quality of life in patient with recurrent or metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer agents according to the results of pharmacogenetic study.

Conditions

  • Recurrent or Metastatic Gastric Cancer

Interventions

DRUG

SP

\<Every 3 weeks\> 1. Day 1\~14 : TS-1 80mg/m2/day (PO), 2. Day 1 : CDDP 60mg/m2/day IVF 2hours, 3. Day 15\~21 : Rest.

DRUG

FL/Tax

\<Every q 3 weeks\> 1. Day1 : Paclitaxel 175mg/m2 IVF for 2hours 2. Day1 : Leucovorin 20mg/m2 IVF for 1hour 3. Day1\~3 : 5-FU 1000mg/m2 IVF for 24hours

DRUG

FL/Doc

\<Every q 3 weeks\> 1. Day1 : Docetaxel 75mg/m2 IVF for 1hour 2. Day1 : Leucovorin 20mg/m2 IVF for 1hour 3. Day1\~3 : 5-FU 1000mg/m2 IVF for 24hours

DRUG

FOLFOX

\<Every q 2 weeks\> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1\~2 : 5-FU 1200mg/m2 IVF for 24hours

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-09
Primary Completion
2016-07-25
Completion
2016-07-25

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01283204 on ClinicalTrials.gov