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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470742

Enrollment

Registered

2011-11-11

Start date

2010-09-30

Completion date

2015-12-31

Last updated

2019-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Brief summary

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.

Interventions

DRUGXELOX

D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks

DRUGXELODA

Capecitabine 1000mg/m2 bid D1-14 every 3weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)	36months

Secondary

Measure	Time frame
response rate	36months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026