The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer (GZH-001)

January 15, 2014 updated by: Chengya Chou, The Second People's Hospital of Sichuan

Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • male or female
  • Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
  • ECOG performance status score 0-2 ;
  • Expected survival time more than three months ;
  • Adequate hematologic parameters and liver and kidney function ;
  • Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
  • Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
  • Renal : serum creatinine ≤ ULN ;
  • Informed consent of patients or their agents , and signed informed consent.

Exclusion Criteria:

  • For patients allergic to capecitabine ;
  • Patients with CNS metastases
  • Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
  • Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
  • Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
  • Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
  • The researchers believe that this test is not suitable for those who participate .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance.
Drug: Paclitaxel
Drug: Oxaliplatin and Capecitabine
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial.
Placebo Comparator: B
Observation until progression
Drug: Paclitaxel
Drug: Oxaliplatin and Capecitabine
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival (OS)
Time Frame: from the date of randomization until death from any cause or up to 1 year
from the date of randomization until death from any cause or up to 1 year
adverse events (AE)
Time Frame: from date of randomization to 28 days after the last chemo dosage
from date of randomization to 28 days after the last chemo dosage
health-related quality of life (HRQOL
Time Frame: evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second People's Hospital of Sichuan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2ndSichuan
  • GZH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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