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Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

every six weeks

Safety Issue:


Principal Investigator

Jiliang Ying, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

May 2007

Completion Date:

December 2011

Related Keywords:

  • Gastric Cancer
  • Time to Progression
  • Overall survival
  • Response rate
  • Quality of Live
  • Toxicities
  • Stomach Neoplasms