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A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

Phase 2
30 Years
70 Years
Not Enrolling
Stomach Neoplasms, Gastric Cancer

Thank you

Trial Information

A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

The study hypothesis is that the 5 year survival rate will reach 35% from 25% when
neoadjuvant chemotherapy is carried out. With the alpha value to be 0.05 and beta value to
be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.

Inclusion Criteria:

- ECOG score 0-2

- Ambulatory males or females, aged 30-70 years.

- Histologically confirmed gastric adenocarcinoma, staged preoperatively AJCC/UICC
stage III(T3N1,T2N2,T4N0,T3N2)and IVM0 and operable

- Life expectancy more than 3 months

- Give written informed consent prior to study specific screening procedures, with the
understanding that the patient has the right to withdraw from the study at any time,
without prejudice.

- Normal hepatic, renal, and bone marrow function (GPT<2 fold of upper limit value;
WBC>4000/dl, Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value)

Exclusion Criteria:

- Patients can not bear surgical procedure.

- Pregnant or lactating women or women do not agree conceptive procedures.

- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except
corticosteroids, for the currently treated gastric cancer.

- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix.

- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the Investigator to be clinically significant precluding
informed consent or interfering with compliance for oral drug intake.

- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery
disease, New York Heart Association (NYHA) grade II or greater congestive heart
failure or serious cardiac arrhythmia requiring medication or myocardial infarction
within the last 12 months.

- Organ allografts requiring immunosuppressive therapy.

- Serious uncontrolled intercurrent infections or other serious uncontrolled
concomitant disease.

- Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal

- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without
documented DPD deficiency) or patients with known dihydropyrimidine dehydrogenase
(DPD) deficiency.

- Hypersensitivity to platinum compounds or any of the components of the study

- Received any investigational drug or agent/procedure, i.e. participation in another
trial, within 4 weeks before randomization.

- Unwilling or unable to comply with the protocol for the duration of the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

5 year overall survival

Outcome Time Frame:

Jan 2008 to Dec 2012

Safety Issue:


Principal Investigator

Jiafu Ji, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University


China: Ethics Committee

Study ID:




Start Date:

January 2008

Completion Date:

December 2012

Related Keywords:

  • Stomach Neoplasms
  • Gastric Cancer
  • gastric adenocarcinoma
  • neoadjuvant chemotherapy
  • efficacy
  • safety
  • chemotherapy
  • Neoplasms
  • Stomach Neoplasms