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Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer

Phase 2
18 Years
Open (Enrolling)
Gastrointestinal Cancer

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Trial Information

Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer

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.

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

- 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

- 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;

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response

Outcome Description:

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.

Outcome Time Frame:

Every eight weeks

Safety Issue:


Principal Investigator

WENCHAO LIU, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

xijing hospital of the fourth military medical univercity


China: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

August 2018

Related Keywords:

  • Gastrointestinal Cancer
  • S-1
  • Oxaliplatin
  • Dihydropyrimidine Dehydrogenase
  • Gastrointestinal Neoplasms