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Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study

NCT03368131 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-02-19

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction

Conditions

  • Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Trastuzumab

intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle

DRUG

Capecitabine

825\~1000mg/m2 bid d1-14

DRUG

Oxaliplatin

130 mg/m2 Ivgtt d1 q3w

RADIATION

Radiotherapy

45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）

Sponsors & Collaborators

  • Hebei Medical University

    lead OTHER

Principal Investigators

  • Qun Zhao · Hebei Medical University Fourth Hospital

  • Jun Wang · Hebei Medical University Fourth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-12-30
Completion
2020-12-31

Countries

  • China

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 NCT03368131 on ClinicalTrials.gov