A Efficacy and Tolerability Study of TEGAFOX Sequential S-1 in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

June 26, 2016 updated by: Xiao Chen, MD, LanZhou University

A Efficacy and Tolerability Study of Uracil/Ftorafur/Leucovorin Combined With Oxaliplatin (TEGAFOX) Sequential S-1 or SOX Sequential S-1 and S-1 Monotherapy in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Gansu
      • LanZhou, Gansu, China, 0931
        • Recruiting
        • Second Hospital Affiliated to Lanzhou University
        • Contact:
        • Principal Investigator:
          • XIAO CHEN, Professor

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:

  • 75≧Age≧18
  • Histologically or cytologically confirmed gastrointestinal cancer
  • Stage Ⅱ or Ⅲ or Ⅳ
  • ECOG ≦2
  • Accept the gastric cancer radical resection
  • Life expectancy of at least three months
  • Written informed consent to participate in the trial

Exclusion Criteria:

  • History of severe hypersensitivity reactions to the ingredients of S-1\TF\5-FU/calcium folinate or oxaliplatin

  • Inadequate hematopoietic function which is defined as below:

    • white blood cell (WBC) less than 5x10^9/L
    • absolute neutrophil count (ANC) less than 2x10^9/L
    • platelets less than 100*10^9/L

  • Inadequate hepatic or renal function which is defined as below:

    • serum bilirubin greater than 2 times the upper limit of normal range
    • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
    • blood creatinine level greater than 2 times ULN
  • Presence of peripheral neuropathy
  • Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
  • Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
  • Psychiatric disorder or symptom that makes participation of the patient difficult;
  • Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months
  • Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes

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
Active Comparator: SOX Sequential S-1 Group
Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months
Drug: SOX Sequential S-1
8 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle.
Active Comparator: SOX Group
Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months
Drug: SOX
S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle
Experimental: TEGAFOX Sequential S-1
Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months
Drug: TEGAFOX Sequential S-1.
6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survial (OS)
Time Frame: Event driven, an expected average of 48 months
Event driven, an expected average of 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survial
Time Frame: Event driven, an expected average of 24 months
Event driven, an expected average of 24 months
Safety (Adverse Events)
Time Frame: Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 3week
Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 3week
Dose intensity
Time Frame: Event driven, an expected average of 48 months
Dose intensity will be used for present patients' compliance
Event driven, an expected average of 48 months

Collaborators and Investigators

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

Sponsor

LanZhou University

Investigators

  • Principal Investigator: Xiao Chen, MD, Second Hospital Affiliated to Lanzhou 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

May 1, 2013

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 26, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 26, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013078

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.

Clinical Trials on Gastric Cancer

Clinical Trials on SOX Sequential S-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe