NCT00591045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
263

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 11, 2008

Status Verified

December 1, 2007

Enrollment Period

4.9 years

First QC Date

December 31, 2007

Last Update Submit

January 10, 2008

Conditions

Stomach NeoplasmsGastric Cancer

Keywords

gastric adenocarcinomaneoadjuvant chemotherapyefficacysafetychemotherapy

Outcome Measures

Primary Outcomes (1)

  • 5 year overall survival

    Jan 2008 to Dec 2012

Secondary Outcomes (1)

  • R0 resection rate

    Jan 2008 to Dec 2012

Study Arms (2)

1

EXPERIMENTAL

The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.

Drug: mFOLFOX

2

NO INTERVENTION

No neoadjuvant chemotherapy and surgery and then adjuvant chemotherapy.

Interventions

mFOLFOXDRUG

oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ

1

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University School of Oncology

Beijing, Beijing Municipality, 100036, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jiafu Ji, M.D.

    Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiwen Wu, M.D.

CONTACT

86-10-88196050wuaw@sina.com

Jiafu Ji, M.D.

CONTACT

86-10-88196048jiafuj@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 11, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 11, 2008

Record last verified: 2007-12

Locations

CN(1)