Clinical trial · Interventional
Sequential Chemotherapy With Xelox Follows by TX to Treat Gastric Cancer
A Phase II Study of Sequential Capecitabine Plus Oxaliplatin (XELOX) Followed by Docetaxel Plus Capecitabine (TX) in Patients With Unresectable Gastric
NCT01331928CI-TRIAL-00004662unknownPhase 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 determine whether sequential chemotherapy with capecitabine plus oxaliplatin (Xelox) followed by docetaxel plus capecitabine (TX)in unresectable 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 (Xeloda, Roche), Oxaliplatin (Sanofi-Aventis), Docetaxel (Sanofi-Aventis) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine, Oxaliplatin, Docetaxel , Gastric cancer
- interventionNames
- Drug: Capecitabine (Xeloda, Roche), Oxaliplatin (Sanofi-Aventis), Docetaxel (Sanofi-Aventis)
Primary outcomes (1)
- measure
- objective tumor response rate
- timeFrame
- 2 year
- description
- Analysis for the objective response rate will be conducted on both the intention-to-treat (ITT) and evaluable data sets. Response will be assessed by Response Evaluation Criteria in Solid Tumor (RECIST 1.1).The analysis will be in descriptive statistics, presented by point estimate and 95% confidence interval for the efficacy variable (Objective tumor response rate)
Secondary outcomes (1)
- measure
- the progression-free survival, overall survival, toxicity profiles
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed gastric adenocarcinoma. * At least one measurable lesion in a non-irradiated area. * No prior exposure to systemic chemotherapy for advanced gastric cancer. * For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment. * Aged \> 20 years old. * ECOG Performance Status \<= 2. * Life expectancy greater than 12 weeks. * Adequate bone marrow function * Adequate liver function * Adequate renal function Exclusion Criteria: * Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy. (Previous radiotherapy is allowable if the last dose was given more than 1 month before the protocol treatment). * Major surgery within two weeks prior to entering the study. * Patients with CNS metastasis, including clinical suspicion. * Patients who are under active or uncontrolled infections. * Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry. * Patients with clinically detectable peripheral neuropathy \> 2 on the CTC criteria * Patients with concomitant illness that might be aggravated by chemotherapy. * Patients who are pregnant or with breast feeding. * Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only. * Patients with hypersensitivity to any component of the chemotherapeutic regimen. * mental status is not fit for clinical trial * can not take study medication orally * fertile men and women unless using a reliable and appropriate contraceptive method
References
Publications (0)
Data not yet available
No reference posted for this study.