Gastrointestinal Cancer
Conditions
Keywords
S-1, Oxaliplatin, Dihydropyrimidine Dehydrogenase
Brief summary
In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.
Detailed description
A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against gastrointestinal carcinoma. In this study, the relationship between activity of DPD in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.
Interventions
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≧18; * Histologically or cytologically confirmed gastrointestinal cancer； * ECOG ≦2; * Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment; * 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 or oxaliplatin; * Inadequate hematopoietic function which is defined as below: * white blood cell (WBC) less than 3,500/mm\^3 * absolute neutrophil count (ANC) less than 1,500/mm\^3 * platelets less than 80,000/mm\^3 * Inadequate hepatic or renal function which is defined as below: * serum bilirubin greater than 1.5 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; * Known DPD deficiency; * Receiving a concomitant treatment with sorivudine or Brivudine within two months;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective tumor response | Every eight weeks | Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Three year | The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model. |
| Progress-free survival | one year | The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model. |
| Adverse event incidence | One year | The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model. |
Countries
China
Contacts
Primary ContactWENCHAO LIU, Professor
Outcome results
None listed