Status:
TERMINATED
Effects of S-1 and Capecitabine on Coronary Artery Blood Flow
Lead Sponsor:
Heikki Joensuu
Conditions:
Esophagus Cancer
Stomach Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is infrequent, but subclinic...
Detailed Description
Patients diagnosed with adenocarcinoma of the gastroesophageal tract are randomly assigned to receive two 3-weekly cycles of either XELOX (intravenous oxaliplatin 130 mg/m2 d.1 followed by oral capeci...
Eligibility Criteria
Inclusion
- Has given written informed consent.
- Is at least 18 years of age.
- Has advanced or metastatic gastrointestinal tract adenocarcinoma.
- No previous cancer chemotherapy for cancer.
- Measurable or evaluable lesions according to RECIST v1.1 criteria.
- Is able to take medications orally.
- Has ECOG performance status 0 or 1.
- Has a life expectancy of at least 3 months.
- Has adequate organ function.
Exclusion
- Cancer considered operable without prior chemotherapy.
- Prior chemotherapy to cancer.
- Previous therapy with fluoropyrimidines or anthracyclines for any indication.
- Inability to swallow tablets.
- Known brain metastasis or leptomeningeal metastasis.
- History of myocardial infarction, coronary stenting/graft.
- History of unstable angina, coronary/peripheral artery bypass graft.
- History of cerebrovascular accident or transient ischemic attack.
- History of pulmonary embolism or deep vein thrombosis.
- Symptomatic congestive heart failure.
- Ongoing cardiac dysrhythmias.
- Patients with any cardiac disease that requires regular medication.
- Hypertensive crisis or severe hypertension that is not controlled.
- Is a pregnant or lactating female.
- The cardiac arterial flow tests cannot be done.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02216149
Start Date
January 1 2015
End Date
August 1 2018
Last Update
August 28 2018
Active Locations (1)
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1
Helsinki University Central Hospital
Helsinki, Finland, 00029