Esophagus CancerPhase 2FluoHeartNCT02216149
Effects of S-1 and Capecitabine on Coronary Artery Blood Flow
A Phase 2 study testing S-1, Capecitabine and Oxaliplatin in people with Esophagus Cancer and Stomach Cancer, run by Heikki Joensuu at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Esophagus Cancer, Stomach Cancer, Small Bowel Cancer
- What is being tested?
- S-1, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2015to Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Has ECOG performance status 0 or 1.
- Has a life expectancy of at least 3 months.
- Has adequate organ function.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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 capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14) or SOX (intravenous oxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14). A cross-over between the 2 arms is carried out after the first 2 cycles; patients allocated to XELOX will receive 2 cycles of SOX (cycles 3 and 4), and those allocated to SOX will receive XELOX (cycles 3 and 4). Monitoring of the coronary artery flow, cardiac arrythmias, cardiac symptoms and blood biochemistry is done at baseline, during each chemotherapy cycle (cycles 1 to 4) and after treatment.Study treatment will continue until all patients have discontinued from treatment or maximum 24 weeks from the date of the first day of treatment, whichever occurs first. At that point, treatment may continue at the discretion of the Investigator. Each patient will be followed for survival status for a minimum of 12 months after first dose of study medication. Tumor assessments will be performed throughout the study period and analyzed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009). Computed tomography (CT) scans will be performed at the end of every 2 cycles. Cardiac assessments will be performed and analyzed using non-invasive transthoracic Doppler echocardiography, 24-h Holter registration, and plasma troponin concentration.
- Being tested
- S-1, Capecitabine, Oxaliplatin
- Keywords
- fluoropyrimidine, S-1, Teysuno, oxaliplatin, coronary artery flow, coronary artery dysfunction, gastrointestinal tract cancer
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Also called Teysuno, tegafur/gimeracil/oteracil
S-1 25 mg/m2/day BID d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks
CapecitabineDrug
Also called Xeloda
capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin 130 mg/m2 D1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| S-1 plus oxaliplatin (SOX) | Experimental | Oxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14. Receives: Drug: S-1; Drug: Oxaliplatin |
| Oxaliplatin plus capecitabine (XELOX) | Active comparator | Intravenous oxaliplatin 130 mg/m2 d.1 followed by oral capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14. Receives: Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of coronary artery dysfunction
The frequency of subclinical coronary artery dysfunction is as assessed by comparing the coronary flow reserve during chemotherapy with the baseline coronary flow reserve, and the coronary flow response to a cold pressor test.
Measured: 3 months
Secondary outcomes (5)
Coronary artery blood flow rate
The coronary artery blood flow rate is measured with ultrasound. The rates are compared with the baseline and between the groups.
Measured: 3 months
Cardiac arrythmias during 24-hour electrocardiogram registration
Cardiac arrythmias detected with Holter cardiac recording.
Measured: 3 months
Adverse events between the allocation groups
by CTCAE.4
Measured: 3 months
Response to chemotherapy
by RECIST 1.1
Measured: 3 months
Survival status
Survival from the first dose of study medication to study completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heikki Joensuu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heikki Joensuu, Helsinki University Central Hospital
- Investigators
- Heikki Joensuu, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216149
- Sponsor's protocol ID
- HUS-01/2013
- Other IDs
- 2013-003976-11
- Acronym
- FluoHeart
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02216149
- Acronym / sponsor ID
- FluoHeart / HUS-01/2013
- Keywords
- fluoropyrimidine, S-1, Teysuno, oxaliplatin, coronary artery flow, coronary artery dysfunction, gastrointestinal tract cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heikki JoensuuUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14) or SOX (intravenous oxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14). A cross-over between the 2 arms is carried out after the first 2 cycles; patients allocated to XELOX will receive 2 cycles of SOX (cycles 3 and 4), and those allocated to SOX will receive XELOX (cycles 3 and 4). Monitoring of the coronary artery flow, cardiac arrythmias, cardiac symptoms and blood biochemistry is done at baseline, during each chemotherapy cycle (cycles 1 to 4) and after treatment.Study treatment will continue until all patients have discontinued from treatment or maximum 24 weeks from the date of the first day of treatment, whichever occurs first. At that point, treatment may continue at the discretion of the Investigator. Each patient will be followed for survival status for a minimum of 12 months after first dose of study medication. Tumor assessments will be performed throughout the study period and analyzed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009). Computed tomography (CT) scans will be performed at the end of every 2 cycles. Cardiac assessments will be performed and analyzed using non-invasive transthoracic Doppler echocardiography, 24-h Holter registration, and plasma troponin concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1 plus oxaliplatin (SOX) | Experimental | Drug: S-1, Drug: OxaliplatinOxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14. |
| Oxaliplatin plus capecitabine (XELOX) | Active comparator | Drug: Capecitabine, Drug: OxaliplatinIntravenous oxaliplatin 130 mg/m2 d.1 followed by oral capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1Also: Teysuno, tegafur/gimeracil/oteracilS-1 25 mg/m2/day BID d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks | Drug | S-1 plus oxaliplatin (SOX) |
| CapecitabineAlso: Xelodacapecitabine 2000 mg/m2/day divided in 2 daily doses d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks | Drug | Oxaliplatin plus capecitabine (XELOX) |
| OxaliplatinAlso: EloxatinOxaliplatin 130 mg/m2 D1 every 3 weeks | Drug | Oxaliplatin plus capecitabine (XELOX), S-1 plus oxaliplatin (SOX) |
Primary outcome
Frequency of coronary artery dysfunction
Time frame: 3 months
The frequency of subclinical coronary artery dysfunction is as assessed by comparing the coronary flow reserve during chemotherapy with the baseline coronary flow reserve, and the coronary flow response to a cold pressor test.
5 secondary outcomes
Coronary artery blood flow rate
Time frame: 3 months
Cardiac arrythmias during 24-hour electrocardiogram registration
Time frame: 3 months
Adverse events between the allocation groups
Time frame: 3 months
Response to chemotherapy
Time frame: 3 months
Survival status
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki Joensuu, MD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1, Capecitabine and Oxaliplatin in people with Esophagus Cancer and Stomach Cancer, run by Heikki Joensuu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of coronary artery dysfunction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.