NCT01880632

Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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。

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	XELOX	Patients will be given the perioperative chemotherapy as below once recruited: Capecitabine ：500 mg tablets（Roche） Oxaliplatin：50mg/10ml（according to daily practice in each center） Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, 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

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-05-01
• Completion: 2018-08-01
• First posted: 2013-06-19
• Last updated: 2015-12-18

Locations

1 site across 1 country: China