Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma
Status:
Unknown status
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborators:
Fudan University RenJi Hospital Ruijin Hospital Xinhua Hospital, Shanghai Jiao Tong University School of Medicine