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

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00591045

Collaborator

Fudan University (Other), Capital Medical University (Other)

263

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

5 year overall survival [Jan 2008 to Dec 2012]

Secondary Outcome Measures

R0 resection rate [Jan 2008 to Dec 2012]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.