Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591045
Recruitment Status : Unknown
Verified December 2007 by Peking University.
Recruitment status was:  Not yet recruiting
First Posted : January 11, 2008
Last Update Posted : January 11, 2008
Fudan University
Capital Medical University
Information provided by:
Peking University

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Gastric Cancer Drug: mFOLFOX Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.
oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ

No Intervention: 2
No neoadjuvant chemotherapy and surgery and then adjuvant chemotherapy.

Primary Outcome Measures :
  1. 5 year overall survival [ Time Frame: Jan 2008 to Dec 2012 ]

Secondary Outcome Measures :
  1. R0 resection rate [ Time Frame: Jan 2008 to Dec 2012 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591045

Contact: Aiwen Wu, M.D. 86-10-88196050
Contact: Jiafu Ji, M.D. 86-10-88196048

China, Beijing
Peking University School of Oncology Not yet recruiting
Beijing, Beijing, China, 100036
Contact: Jiafu Ji, M.D.    86-10-88196048   
Principal Investigator: Jiafu Ji, M.D.         
Sponsors and Collaborators
Peking University
Fudan University
Capital Medical University
Principal Investigator: Jiafu Ji, M.D. Peking University

Responsible Party: Jiafu Ji, Peking University Identifier: NCT00591045     History of Changes
Other Study ID Numbers: CGCCG-0701
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: December 2007

Keywords provided by Peking University:
gastric adenocarcinoma
neoadjuvant chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances