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
Recruitment status was Not yet recruiting
Sponsor:
Peking University
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
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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
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 May 19, 2013