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

Lanzhou University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: TEGAFOX Sequential S-1.; Drug: SOX; Drug: SOX Sequential S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02817425

2013078

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

SOX Sequential S-1 Group

Active Comparator group

Description:

Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months

Treatment:

Drug: SOX Sequential S-1

SOX Group

Active Comparator group

Description:

Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months

Treatment:

Drug: SOX

TEGAFOX Sequential S-1

Experimental group

Description:

Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months

Treatment:

Drug: TEGAFOX Sequential S-1.