Clinical trial · Interventional
Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
NCT01470742CI-TRIAL-00042522withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We stop because of problems such as insurance.
Summary
Brief summary (as posted)
The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XELODA | Drug | Capecitabine | ALIAS |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- XELODA
- description
- Capecitabine 1000mg/m2 bid D1-14 every 3weeks
- interventionNames
- Drug: XELODA
- type
- EXPERIMENTAL
- label
- XELOX
- description
- D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
- interventionNames
- Drug: XELOX
Primary outcomes (1)
- measure
- Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
- timeFrame
- 36months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 70 2. Histologically or cytologically confirmed adenocarcinoma of the gastric 3. Advanced ,metastatic/recurrence gastric cancer 4. ECOG performance status of 0 to 2 5. Life expectancy≥3months 6. No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is \> 6months from the study entry date) 7. No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization. 8. Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL) 9. Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min) 10. Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT \< normal x 3) 11. provision of a signed written informed consent Exclusion Criteria: 1. History of any medical or psychiatric condition 2. Active infections 3. Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 \>=Grade 1 ) 4. symptomatic brain metastases 5. Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered) 6. History of other malignancy except: Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ 7. Known hypersensitivity to Fluoropyrimidines/platinum 8. Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias) 9. Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
References
Publications (0)
Data not yet available
No reference posted for this study.