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Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma

NCT02858206 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-07-26

No results posted yet for this study

Summary

This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.

Conditions

  • Esophageal Neoplasms

Interventions

RADIATION

IMRT simultaneous integrated boost

To achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively

DRUG

Nimotuzumab

nimotuzumab 400mg per week which start from 1 week before radiotherapy and in the following 4 weeks

DRUG

Paclitaxel

Paclitaxel from 45 to 60 mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks

DRUG

Nedaplatin

Nedaplatin 25mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks

PROCEDURE

Esophagectomy

Radical esophagectomy 4-6 weeks after neoadjuvant therapy

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Affiliated Hospital of Hebei University

    collaborator OTHER

  • Beijing Army General Hospital

    collaborator OTHER_GOV

  • Beijing Hospital

    collaborator OTHER_GOV

  • Peking University First Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • The Affiliated Hospital of Inner Mongolia Medical University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-11-30
Completion
2021-11-30

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 NCT02858206 on ClinicalTrials.gov