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Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive

NCT01503983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-08-27

No results posted yet for this study

Summary

The objective of the study is assess the efficacy and safety of Trastuzumab in combination with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction, (HER2)-positive.

Conditions

  • Stage IV Gastric Cancer With Metastasis

Interventions

DRUG

Trastuzumab

Trastuzumab: 8 mg/kg day 1 followed by 6 mg/kg every 3 weeks (i.v.)

DRUG

Capecitabine

Capecitabine: 1000 mg/m2/12h/days 1 - 14 every 3 weeks (v.o.)

DRUG

Oxaliplatin

Oxaliplatin: 130 mg/m2 in 2 h, day 1 / (i.v.) /every 3 weeks

Sponsors & Collaborators

  • Fundación para el Progreso de la Oncología en Cantabria

    lead OTHER

Principal Investigators

  • Fernando Rivera NA, Doctor · Sponsor represntative

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-12-31
Completion
2015-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT01503983 on ClinicalTrials.gov