FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer (FOLFOX6)

A Phase II Study of Neoadjuvant Chemotherapy With Modified FOLFOX6 Regimen and Effects of Tumor Regression in Locally Advanced Gastric Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer; Surgery; Effects of Chemotherapy
• Intervention / Treatment: Drug: mFOLFOX6 regimen

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Xiao yi Li, Mater; Phone Number: +86(10)69154910; Email: li.xiaoyi@263.net
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Contact: Xiang Wang, Master; Phone Number: +86(10)69158315; Email: wangxiang5123@126.com
      • Principal Investigator: Xiao yi Li, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mFOLFOX6,chemotherapy 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	Drug: mFOLFOX6 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The 3-year disease-free survival rate in the patients who will receive mFOLFOX6 regimen neoadjuvant chemotherapy regimen	3 year

Other Outcome Measures

Outcome Measure	Time Frame
The R0 resection rate in the patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen	9 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Xiang Wang, Master, Department of Medical Oncology Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 24, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): August 27, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: PUMCH-JZ