NCT02226380

Brief Summary

Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a series in local advanced gastric cancer patients. Patients and methods: The study is a prospective non-randomized study. Patients with histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2 lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with postoperative pathologic staging on patients who underwent radical surgery. Tumor down-staging and the grade of pathologic response are included in a statistical correlation between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival, R0 resection rate, toxicity and prediction of response.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

August 27, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

August 24, 2014

Last Update Submit

August 26, 2014

Conditions

Gastric CancerEffects of ChemotherapySurgery

Outcome Measures

Primary Outcomes (1)

  • The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen

    3 years

Secondary Outcomes (1)

  • The 3-year disease-free survival rate in the patients who will receive mFOLFOX6 regimen neoadjuvant chemotherapy regimen

    3 year

Other Outcomes (1)

  • The R0 resection rate in the patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen

    9 weeks

Study Arms (1)

mFOLFOX6,chemotherapy regimen

EXPERIMENTAL

oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery

Drug: mFOLFOX6 regimen

Interventions

mFOLFOX6 regimenDRUG

oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery

mFOLFOX6,chemotherapy regimen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligibility criteria included histologically confirmed gastric cancer, the gastro-oesophageal junction(GEJ) may be involved, but the bulk of the tumour has to be in the stomach; age ≥18 years old, ECOG performance status score ≤2, no prior chemotherapy, TNM stage of T2-T4 or positive regional lymph nodes by endoscopic ultrasound or computed tomography (CT), and adequate hematological, heart, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL).

You may not qualify if:

  • Patients with second malignancies or evidence of severe or uncontrolled systemic disease were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100032, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Related Publications (1)

  • Li ZY, Koh CE, Bu ZD, Wu AW, Zhang LH, Wu XJ, Wu Q, Zong XL, Ren H, Tang L, Zhang XP, Li JY, Hu Y, Shen L, Ji JF. Neoadjuvant chemotherapy with FOLFOX: improved outcomes in Chinese patients with locally advanced gastric cancer. J Surg Oncol. 2012 Jun 15;105(8):793-9. doi: 10.1002/jso.23009. Epub 2011 Dec 20.

    PMID: 22189752RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Xiang Wang, Master

    Department of Medical Oncology Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Xiang Wang, Master

CONTACT

+86 (10) 6915 8315wangxiang5123@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2014

First Posted

August 27, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations

CN(2)