Clinical trial · Interventional
Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
NCT01608646CI-TRIAL-00007029unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 plus oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- S-1 plus oxaliplatin
- description
- 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.
- interventionNames
- Drug: S-1 plus oxaliplatin
Primary outcomes (1)
- measure
- Objective tumor response
- timeFrame
- Every eight weeks
- 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.
Secondary outcomes (3)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.