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

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: Gastric Cancer
• Intervention / Treatment: Drug: SOX Sequential S-1; Drug: SOX; Drug: TEGAFOX Sequential S-1.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Gansu
    • LanZhou, Gansu, China, 0931
      • Recruiting
      • Second Hospital Affiliated to Lanzhou University
      • Contact: WEN QIU; Phone Number: 0931-8487117; Email: qiuwenmm@sina.com
      • Principal Investigator: XIAO CHEN, Professor

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	Event driven, an expected average of 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survial		Event driven, an expected average of 24 months
Safety (Adverse Events)		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	Dose intensity will be used for present patients' compliance	Event driven, an expected average of 48 months

Collaborators and Investigators

• Sponsor: LanZhou University
• Investigators: Principal Investigator: Xiao Chen, MD, Second Hospital Affiliated to Lanzhou University

Study record dates

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: S-1; Adjuvant Chemotherapy; TEGAFOX
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2013078