Clinical trial · Interventional
Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
NCT00568529CI-TRIAL-00003477suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): There are not enough patients enrolled.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine and Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combine Chemotherapy
- description
- XELOX(Xeloda and oxaliplatin combination)
- interventionNames
- Drug: Capecitabine and Oxaliplatin
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 2-6 months
Secondary outcomes (1)
- measure
- time to progression and overall survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 70 years * Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma * ECOG performance status ≤1 * Measurable diseases according to the RECIST * Relapse or refractory after the first-line chemotherapy * Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min). Exclusion Criteria: * Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin * Have used any of drugs in the regimen in first-line chemotherapy * Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection * The evidence of CNS metastasis * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Received other chemotherapy regimen after metastasis * Participated in other clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.