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

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: SOX Sequential S-1; Drug: SOX; Drug: TEGAFOX Sequential S-1.

• Registration Number: NCT02817425
• Lead Sponsor: LanZhou University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-06-08
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-26
• Last Update Submitted: 2016-06-26
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Primary Completion: 2018-04
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOX Sequential S-1 Group	SOX Sequential S-1	Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months
SOX Group	SOX	Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months
TEGAFOX Sequential S-1	TEGAFOX Sequential S-1.	Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months

Primary Outcome Measures

Name	Time	Method
Overall Survial (OS)	Event driven, an expected average of 48 months

Secondary Outcome Measures

Name	Time	Method
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	Event driven, an expected average of 48 months	Dose intensity will be used for present patients' compliance

Trial Locations

Locations (1)

Second Hospital Affiliated to Lanzhou University; 🇨🇳 LanZhou, Gansu, China