- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470742
Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
December 26, 2019 updated by: Won Ki Kang, Samsung Medical Center
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
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.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: XELODA
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
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Capecitabine 1000mg/m2 bid D1-14 every 3weeks
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EXPERIMENTAL: XELOX
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
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D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
Time Frame: 36months
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36months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response rate
Time Frame: 36months
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36months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
February 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
November 7, 2011
First Submitted That Met QC Criteria
November 9, 2011
First Posted (ESTIMATE)
November 11, 2011
Study Record Updates
Last Update Posted (ACTUAL)
December 30, 2019
Last Update Submitted That Met QC Criteria
December 26, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-04-118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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