Efficacy and Safety Study of a Modified SOX Regimen in First-Line Treatment of Unresectable Gastric Adenocarcinoma (mSOX)

March 27, 2012 updated by: Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

A Phase II Trial Evaluate a Modified SOX Regimen in First-Line Treatment of Unresectable Gastric Adenocarcinoma

This is an open-label, phase II study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and S-1 on unresectable gastric adenocarcinoma in the first-line therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Study Type

Interventional

Enrollment (Anticipated)

30

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.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent;
  • Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2;
  • Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination;
  • At least 3 weeks since last major surgery;
  • At least 12 months since last adjuvant chemotherapy;
  • At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected;
  • Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields;
  • Patients with reproductive potential must use effective BC;

  • Required Screening Laboratory Criteria:

    • Hemoglobin 90g/L
    • WBC 3.5 x 109/L
    • Neutrophils 1.5 x 109/L
    • Platelets 100 x 109/L
    • Creatinine 133 umol/L and creatinine clearance 60 mL/min
  • A probable life expectancy of at least 6 months;

Exclusion Criteria:

  • Brain metastases;
  • Female of childbearing potential, pregnancy test is positive;
  • Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer;
  • Active infection;
  • Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk;
  • Sexually active patients refusing to practice adequate contraception;
  • Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator;
  • History of grade 3 or 4 toxicity to fluoropyrimidines;
  • Pre-existing neuropathy ≥ NCI CTC grade 2.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate according to RECIST 1.1
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year
Time to progression
Time Frame: One year
One year
safety data of this regimen
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

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

March 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHMO-02

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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