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

L

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)

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.

Trial contacts and locations

1

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Central trial contact

Xiao Chen, MD

Data sourced from clinicaltrials.gov

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