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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Peking University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Fudan University
Capital Medical University
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT00591045
First received: December 31, 2007
Last updated: January 10, 2008
Last verified: December 2007

December 31, 2007
January 10, 2008
January 2008
December 2012   (final data collection date for primary outcome measure)
5 year overall survival [ Time Frame: Jan 2008 to Dec 2012 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00591045 on ClinicalTrials.gov Archive Site
R0 resection rate [ Time Frame: Jan 2008 to Dec 2012 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Stomach Neoplasms
  • Gastric Cancer
Drug: mFOLFOX
oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ
  • Experimental: 1
    The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.
    Intervention: Drug: mFOLFOX
  • No Intervention: 2
    No neoadjuvant chemotherapy and surgery and then adjuvant chemotherapy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
263
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact: Aiwen Wu, M.D. 86-10-88196050 wuaw@sina.com
Contact: Jiafu Ji, M.D. 86-10-88196048 jiafuj@hotmail.com
China
 
NCT00591045
CGCCG-0701
Yes
Jiafu Ji, Peking University
Peking University
  • Fudan University
  • Capital Medical University
Principal Investigator: Jiafu Ji, M.D. Peking University
Peking University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP