Clinical trial · Interventional
Effects of S-1 and Capecitabine on Coronary Artery Blood Flow
Effects of S-1 and Capecitabine in Combination With Oxaliplatin on the Coronary Artery Blood Flow in Patients Metastatic Gastrointestinal Tract Adenocarcinoma: a Randomized Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow response to a cold pressor test, in a patient population who are being treated for adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens, either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Esophagus Cancer | — | UNRESOLVED | — |
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
| Small Bowel Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S-1 plus oxaliplatin (SOX)
- description
- Oxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14.
- interventionNames
- Drug: S-1
- Drug: Oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Oxaliplatin plus capecitabine (XELOX)
- description
- Intravenous oxaliplatin 130 mg/m2 d.1 followed by oral capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14.
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Frequency of coronary artery dysfunction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available