Clinical trial · Interventional
Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer
A Randomized Phase II Study of Docetaxel vs. Docetaxel Plus Cisplatin vs. Docetaxel Plus S-1 as Second-line Chemotherapy After Cisplatin Plus S-1 or Capecitabine in Metastatic Gastric Cancer
NCT00980603CI-TRIAL-00002653unknownPhase 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)
The purpose of this study is to assess efficacy and safety of docetaxel alone, docetaxel plus cisplatin, and docetaxel plus S-1 in patients with metastatic gastric cancer after failing 1st line chemotherapy with cisplatin plus S-1 or capecitabine
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| docetaxel, cisplatin | Drug | — | UNRESOLVED |
| docetaxel, S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- docetaxel
- interventionNames
- Drug: docetaxel
- type
- EXPERIMENTAL
- label
- doctaxel plus cisplatin
- interventionNames
- Drug: docetaxel, cisplatin
- type
- EXPERIMENTAL
- label
- docetaxel plus S-1
- interventionNames
- Drug: docetaxel, S-1
Primary outcomes (1)
- measure
- response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed gastric adenocarcinoma with metastatic disease * Age ≥18 years * Eastern Cooperative Oncology Group performance status 0-2 * At least one measurable lesion as defined by RECIST * Only one prior chemotherapy containing both S-1 or capecitabine and cisplatin for metastatic gastric cancer with documented progression of disease occurring during chemotherapy or within 6 months of completion of chemotherapy * Adequate major organ function: ANC ≥1,500/mm3, Platelet ≥100,000/mm3, serum bilirubin ≤1.5 x upper limit of normal (ULN), AST/ALT ≤2.5 x ULN (≤5 x ULN if liver metastases are present), creatinine clearance ≥50 ml/min using the calculation formula or 24 hours urine collection * Patients should sign a written informed consent before study entry Exclusion Criteria: * Prior taxane treatment * Major surgery or radiotherapy less than 4 weeks prior to entry * NCI CTCAE (version 3.0) adverse events ≥grade 2 except alopecia, fatigue, and weight loss * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or inability to take oral medication * Patients with active gastrointestinal bleeding * Inadequate cardiovascular function * Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy * Other malignancy within the past 3 years except adequately treated non-melanomatous skin cancer, carcinoma in situ of the cervix, or in situ of prostate cancer Gleason≤7 * Psychiatric disorder that would preclude compliance * Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol * Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
References
Publications (0)
Data not yet available
No reference posted for this study.