Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
This trial is active, not recruiting.
|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.
|Intervention model||parallel assignment|
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
time frame: 36months
time frame: 36months
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)
|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|
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