Clinical trial · Interventional
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma
- 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 compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m\^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m\^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 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 | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Capecitabine + Oxaliplatin
- description
- Patients will receive oral capecitabine (1000 mg/m\^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m\^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months).
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
- type
- NO_INTERVENTION
- label
- Observation
- description
- Participants will not receive any treatment but will be seen regularly by a physician.
Primary outcomes (1)
- measure
- Disease-free survival rate
- timeFrame
- 3 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants greater than or equal to (\>=) 18 years of age * Gastric adenocarcinoma, Stage II, IIIa or IIIb * Potentially curative resection of tumor within 6 weeks prior to randomization * Previously untreated with chemotherapy or radiotherapy Exclusion Criteria: * Serious concomitant medical illnesses that would limit life expectancy to less than (\<) 5 years * Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study * Any evidence of metastatic disease (including presence of tumor cells in the ascites)
References
Publications (0)
Data not yet available