Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma
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.
Timeline
- Start
- 2013-07
- Primary completion
- 2016-05
- Completion
- 2018-08
Outcome
Missed primary endpoint
paper The projected endpoint was not met. PMID 31239311 ↗
paper results did not meet the primary endpoint. PMID 31239311 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |