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

NCT01880632 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-12-18

No results posted yet for this study

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.

Conditions

  • Gastric Adenocarcinoma

Interventions

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

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Tianshu Liu, Doctor · Medical oncology Shanghai zhongshan hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-05-31
Completion
2018-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01880632 on ClinicalTrials.gov