Back to resultsContinuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
EOF5
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Time to Progression, Overall survival, Response rate, Quality of Live, Toxicities
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EOF5 Group
Arm Description
The regimen of 5-day Continuous infusion of FU combined with Epirubicin and Oxaliplatin will be used in the patients recruited in this trial.
Outcomes
Primary Outcome Measures
Time to progression
Secondary Outcome Measures
Toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00767377
Brief Title
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
Official Title
Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Time to Progression, Overall survival, Response rate, Quality of Live, Toxicities
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EOF5 Group
Arm Type
Experimental
Arm Description
The regimen of 5-day Continuous infusion of FU combined with Epirubicin and Oxaliplatin will be used in the patients recruited in this trial.
Intervention Type
Drug
Intervention Name(s)
EOF5
Other Intervention Name(s)
treatment group
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
every six weeks
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
PET Scan response
Description
Patients enrolled in this trial would received 18F-FLT PET SACN and 18F-FDG PET SACN before and 14 days after the first cycle chemotherapy respectively.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiliang Ying, M.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
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