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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01470742
• Other study ID #: 2010-04-118
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)		36months
Secondary	response rate		36months