Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

Phase 3

Withdrawn

• Conditions: Gastric Cancer
• Interventions: Drug: XELODA; Drug: XELOX

• Registration Number: NCT01470742
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Primary Completion: 2015-02
• Study Completion: 2015-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)	36months

Secondary Outcome Measures

Name	Time	Method
response rate	36months

Trial Locations

Locations (1)

Samsung medical Center; 🇰🇷 Seoul, Korea, Republic of