Clinical trial NCT00591045: Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
Official title: A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Gastric Cancer
Keywords: gastric adenocarcinoma
neoadjuvant chemotherapy
efficacy
safety
chemotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Capital Medical University
First posted: 2008-01-11
Enrollment: 263
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric cancer.

Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.

Detailed description: 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.

Eligibility criteria: 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 (ULN).
* 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 medications.
* 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.

Primary outcomes:
measure: 5 year overall survival
timeFrame: Jan 2008 to Dec 2012
Secondary outcomes:
measure: R0 resection rate
timeFrame: Jan 2008 to Dec 2012
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University School of Oncology
state: Beijing
Study officials:
affiliation: Peking University
name: Jiafu Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
References: