FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer
Conditions
Gastric Cancer - Effects of Chemotherapy - Surgery
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: mFOLFOX6 regimen
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

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).

Exclusion Criteria:

Patients with second malignancies or evidence of severe or uncontrolled systemic disease were excluded.
Locations
Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China
Status: Recruiting
Contact: Xiang Wang, Master - +86(10)69158315 - wangxiang5123@126.com
Peking Union Medical College Hospital
Beijing, Beijing, China
Status: Recruiting
Contact: Xiao yi Li, Mater - +86(10)69154910 - li.xiaoyi@263.net
Start Date
October 2013
Sponsors
Peking Union Medical College Hospital
Source
Peking Union Medical College Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page