Back to resultsTrial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
XELOX
XELODA
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 70
- Histologically or cytologically confirmed adenocarcinoma of the gastric
- Advanced ,metastatic/recurrence gastric cancer
- ECOG performance status of 0 to 2
- Life expectancy≥3months
- 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)
- 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.
- Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
- Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
- Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3)
- provision of a signed written informed consent
Exclusion Criteria:
- History of any medical or psychiatric condition
- Active infections
- Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
- symptomatic brain metastases
- Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
History of other malignancy except:
Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
- Known hypersensitivity to Fluoropyrimidines/platinum
- Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
- Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
Sites / Locations
- Samsung medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
XELODA
XELOX
Arm Description
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
Outcomes
Primary Outcome Measures
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
Secondary Outcome Measures
response rate
Full Information
NCT ID
NCT01470742
First Posted
November 7, 2011
Last Updated
December 26, 2019
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01470742
Brief Title
Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
We stop because of problems such as insurance.
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XELODA
Arm Type
Active Comparator
Arm Description
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
Arm Title
XELOX
Arm Type
Experimental
Arm Description
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
Intervention Type
Drug
Intervention Name(s)
XELOX
Intervention Description
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
Intervention Type
Drug
Intervention Name(s)
XELODA
Intervention Description
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
Primary Outcome Measure Information:
Title
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
Time Frame
36months
Secondary Outcome Measure Information:
Title
response rate
Time Frame
36months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 70
Histologically or cytologically confirmed adenocarcinoma of the gastric
Advanced ,metastatic/recurrence gastric cancer
ECOG performance status of 0 to 2
Life expectancy≥3months
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)
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.
Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3)
provision of a signed written informed consent
Exclusion Criteria:
History of any medical or psychiatric condition
Active infections
Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
symptomatic brain metastases
Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
History of other malignancy except:
Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
Known hypersensitivity to Fluoropyrimidines/platinum
Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
Facility Information:
Facility Name
Samsung medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
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