Gastric Cancer, Effects of Chemotherapy, Surgery
Conditions
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.
Interventions
DRUGmFOLFOX6 regimen
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
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| The 3-year disease-free survival rate in the patients who will receive mFOLFOX6 regimen neoadjuvant chemotherapy regimen | 3 year |
Other
| Measure | Time frame |
|---|---|
| The R0 resection rate in the patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen | 9 weeks |
Countries
China
Contacts
Primary ContactXiang Wang, Master
Outcome results
None listed