Clinical trial · Interventional
XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)
XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)
NCT03399110CI-TRIAL-00123557completedPhase 3ClinicalTrials.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)
Our study aims to compare 4 months versus 6 months of adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in patients with gastric cancer. Hypothesis: We hypothesize that a 4-month regimen of capecitabine plus oxaliplatin is noninferior to a 6-month regimen with respect to DFS and is associated with lower treatment-related toxicity.
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
- XELOX for 4 months
- description
- Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 6 cycles (A minimum of 5 cycles was permitted only for patients who could not tolerate full-dose therapy due to unacceptable toxicity), each lasting 3 weeks: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for approximately 4 months.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- XELOX for 6 months
- description
- Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of eight 3-week cycles: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 6 months.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 80 years. 2. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, staged as II, IIIA, or IIIB according to the American Joint Committee on Cancer classification system, eighth edition. 3. Underwent R0 gastrectomy with D2 lymphadenectomy. 4. No other concurrent malignancies. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. No contraindications to chemotherapy. Exclusion Criteria: 1. Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy. 2. Patients with stage I, IIIC, or IV gastric cancer. 3. Severe cardiac, pulmonary, neurologic, hepatic, or other major organ dysfunction. 4. Known or suspected drug allergies. 5. Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.