Clinical trial · Interventional
A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With 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 study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 5-Fluorouracil + Cisplatin
- description
- Participants will receive 5-FU in combination with cisplatin upto disease progression.
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Capecitabine + Cisplatin
- description
- Participants will receive capecitabine in combination with cisplatin upto disease progression.
- interventionNames
- Drug: Capecitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Time to disease progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Adults 18 to 75 years of age * Advanced and/or metastatic gastric cancer with at least 1 measurable lesion Exclusion Criteria: * Uncontrolled infection * Evidence of central nervous system (CNS) metastases * History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix * Radiation therapy or major surgery within 4 weeks of study drug * Previous chemotherapy
References
Publications (1)
- DERIVEDChen J, Xiong J, Wang J, Zheng L, Gao Y, Guan Z. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data from the ML17032 phase III clinical trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e310-e316. doi: 10.1111/ajco.12832. Epub 2018 Jan 26. PMID 29372626