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A Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin as First-line Chemotherapy for Inoperable, Locally Advanced or Recurrent and/or Metastatic Gastric Cancer

NCT01364493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-05-09

No results posted yet for this study

Summary

Although the overall incidence of gastric cancer has steadily declined in many Western countries during the last few decades, it is still one of the most common tumors in China. It is now well recognised that combination chemotherapy regimens improve patient outcomes, but there is no accepted global standard regimen for advanced gastric cancer.

The ToGA study was the first randomized, prospective, multicenter, phase III trial to show the efficacy and safety of Trastuzumab in HER2- positive GC. Trastuzumab reduced the risk of death by 26% (HR 0.74; 95% CI 0∙60, 0∙91; p=0∙0046) when combined with a reference chemotherapy (Capecitabine plus Cisplatin) and prolonged the median survival by nearly 3 months (from 11.1 to 13.8 months) in patients with HER2-positive(FISH+ or IHC3+) advanced GC.

Oxaliplatin has been shown to be as effective as cisplatin, and exhibits a favorable toxicity profile with a substantially lower rate of nephrotoxicity, ototoxicity, and myelosuppression.

In the current study, the efficacy and safety of Trastuzumab in combination with Oxaliplatin/capecitabine chemotherapy will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer.

Conditions

Interventions

DRUG

Trastuzumab+Capecitabine+Oxaliplatin

Trastuzumab will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks. Capecitabine 2000mg/m2d, d1-14; q3w, Trastuzumab and capecitabine are to be continued until disease progression or intolerable toxicity. Oxaliplatin 130mg/m2 d1; q3w, 6 cycles

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-08-31
Completion
2014-02-28

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT01364493 on ClinicalTrials.gov