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
  Purpose

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 Intervention Phase
Stomach Neoplasms
Gastric Cancer
Drug: mFOLFOX
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • 5 year overall survival [ Time Frame: Jan 2008 to Dec 2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • R0 resection rate [ Time Frame: Jan 2008 to Dec 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 263
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.
Drug: mFOLFOX
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.

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591045

Contacts
Contact: Aiwen Wu, M.D. 86-10-88196050 wuaw@sina.com
Contact: Jiafu Ji, M.D. 86-10-88196048 jiafuj@hotmail.com

Locations
China, Beijing
Peking University School of Oncology Not yet recruiting
Beijing, Beijing, China, 100036
Contact: Jiafu Ji, M.D.    86-10-88196048    jiafuj@hotmail.com   
Principal Investigator: Jiafu Ji, M.D.         
Sponsors and Collaborators
Peking University
Fudan University
Capital Medical University
Investigators
Principal Investigator: Jiafu Ji, M.D. Peking University
  More Information

No publications provided

Responsible Party: Jiafu Ji, Peking University
ClinicalTrials.gov Identifier: NCT00591045     History of Changes
Other Study ID Numbers: CGCCG-0701
Study First Received: December 31, 2007
Last Updated: January 10, 2008
Health Authority: China: Ethics Committee

Keywords provided by Peking University:
gastric adenocarcinoma
neoadjuvant chemotherapy
efficacy
safety
chemotherapy

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on September 14, 2014