This trial is active, not recruiting.

Condition gastric cancer
Treatments xelox, xeloda
Phase phase 3
Sponsor Samsung Medical Center
Start date September 2010
End date February 2015
Trial size 200 participants
Trial identifier NCT01470742, 2010-04-118


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks

Primary Outcomes

Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
time frame: 36months

Secondary Outcomes

response rate
time frame: 36months

Eligibility Criteria

Male or female participants at least 70 years old.

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)

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Samsung Medical Center.