Gastric Cancer
Conditions
Keywords
S-1, Adjuvant Chemotherapy, TEGAFOX
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.
Interventions
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.
DRUGSOX
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
DRUGTEGAFOX 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.
Sponsors
LanZhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survial (OS) | Event driven, an expected average of 48 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXiao Chen, MD
Outcome results
None listed