Clinical trial · Interventional
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer
- 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)
This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Oxaliplatin
- Drug: capecitabine [Xeloda]
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Event driven
Secondary outcomes (2)
- measure
- Time to disease progression, overall survival, duration of response, time to response.
- timeFrame
- Event driven
- measure
- AEs, laboratory parameters.
- timeFrame
- Throughout study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>=18 years of age; * gastric cancer with unresectable locally advanced and/or metastatic disease; * \>=1 measurable lesion; * ambulatory, with ECOG Performance Status \>=1. Exclusion Criteria: * previous chemotherapy (except adjuvant or neoadjuvant treatment \>=6 months prior to enrollment); * clinically significant cardiac disease or myocardial infarction within last 12 months; * CNS metastases; * history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.
References
Publications (0)
Data not yet available