Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma — Neo-Classic  

Gastric Adenocarcinoma Clinical Trial

Official title: A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma

Status Recruiting

Clinical Trial Summary

1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.

2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.

Secondary objectives:

• The progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);

• percentage of pathological response ; percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments;

• D2 resection -rate after neoadjuvant chemotherapy of XELOX;

• Overall survival;

• QOL during the whole period of treatment.

3. Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.

4. Treatment plan:Patients will be given the perioperative chemotherapy as below once recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week)Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks.

5. Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of gastric operations in China, more than 500 per year.

Clinical Trial Description

1. Disease specific inclusion criteria:

• Histologically documented gastricadenocarcinoma with Lauren classification Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable

• Measurable disease is required

• Karnofsky score 80%.

• Physical condition and adequate organ function to ensure the success of abdominal surgery.

• Life expectancy ≥12 weeks.

• Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL .Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.

Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.

• Female subjects should not be pregnant or breast-feeding.

• No serious concomitant disease that will threaten the survival of patients to less than 5 years.

2. General inclusion criteria:

• Male or female. Age ≥ 18 years and ≤75 years

• Written (signed) informed consent.

• Able to comply with study and follow-up procedures.

• Good compliance with the treatment plan。

• Consent to provide tissue sample。 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

• NCT number: NCT01880632
• Study type: Interventional
• Source: Shanghai Zhongshan Hospital
• Contact: Tianshu Liu, Doctor
• Phone: +861368 1973 996
• Email: liu.tianshu@zs-hospital.sh.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2013
• Completion date: August 2018