Clinical trial · Interventional
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EOF5 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EOF5 Group
- 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.
- interventionNames
- Drug: EOF5
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- every six weeks
Secondary outcomes (1)
- measure
- Toxicity
- timeFrame
- 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available