Gastric CancerPhase 2NCT00767377
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
A Phase 2 study testing EOF5 in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- EOF5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteChina
- Study dates
- May 2007to Mar 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤2
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- Adequate hepatic, renal, heart, and hematologic functions (platelets >80×109/L, neutrophil>2.0×109/L, serum creatinine ≤1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Who cannot join
- Pregnant or lactating women
- Concurrent cancer
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Neuropathy, brain, or leptomeningeal involvement
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
- Uncontrolled significant comorbid conditions and previous radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer
The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.
Read the detailed description
ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no regimen has been proved to be more effective while less toxicity than ECF regimen. Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical setting in advanced colorectal cancer. It presents a better toxicity profile than cisplatin. Recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion 5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response rates and median overall survival times while resulting in lower rates of grade 3-4 adverse events. Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin and a short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate whether the EOF5 regimen is less toxicity while is comparable effective as ECF regimen.
- Conditions
- Gastric Cancer
- Being tested
- EOF5
- Keywords
- Time to Progression, Overall survival, Response rate, Quality of Live, Toxicities
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOF5Drug
Also called treatment group
epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and 5-FU 375-425 mg/m2/d day 1 through 5 continuous infusion, repeated every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| EOF5 Group | Experimental | The regimen of 5-day Continuous infusion of FU combined with Epirubicin and Oxaliplatin will be used in the patients recruited in this trial. Receives: Drug: EOF5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: every six weeks
Secondary outcomes (1)
Toxicity
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startMay 2007
- Primary completionJul 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
- Investigators
- Jiliang Ying, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767377
- Sponsor's protocol ID
- EOF-MGC
- Status last verified
- Oct 2013
- First submitted
- 6 Oct 2008
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00767377
- Acronym / sponsor ID
- EOF-MGC
- Conditions
- Gastric Cancer
- Keywords
- Time to Progression, Overall survival, Response rate, Quality of Live, Toxicities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Oct 2008 (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.
The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.
Detailed description
ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no regimen has been proved to be more effective while less toxicity than ECF regimen. Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical setting in advanced colorectal cancer. It presents a better toxicity profile than cisplatin. Recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion 5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response rates and median overall survival times while resulting in lower rates of grade 3-4 adverse events. Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin and a short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate whether the EOF5 regimen is less toxicity while is comparable effective as ECF regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EOF5 Group | Experimental | Drug: EOF5The regimen of 5-day Continuous infusion of FU combined with Epirubicin and Oxaliplatin will be used in the patients recruited in this trial. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤2
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- Adequate hepatic, renal, heart, and hematologic functions (platelets >80×109/L, neutrophil>2.0×109/L, serum creatinine ≤1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Concurrent cancer
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Neuropathy, brain, or leptomeningeal involvement
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
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 |
|---|---|---|
| EOF5Also: treatment groupepirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and 5-FU 375-425 mg/m2/d day 1 through 5 continuous infusion, repeated every 3 weeks | Drug | EOF5 Group |
Primary outcome
Time to progression
Time frame: every six weeks
1 secondary outcome
Toxicity
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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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.
Jiliang Ying, M.D principal investigator
Fudan University
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 EOF5 in people with Gastric Cancer, run by Fudan University at 1 site in China.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Oct 2013. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to progression (time frame: every six weeks). 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 16 Oct 2013.