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Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

NCT04027543 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 423

Last updated 2020-05-29

No results posted yet for this study

Summary

To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.

Conditions

  • Radiotherapy Side Effect
  • Chemotherapy Effect
  • Oesophageal Carcinoma
  • Effect of Drugs
  • Safety Issues

Interventions

COMBINATION_PRODUCT

Neoadjuvant chemoradiotherapy

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

PROCEDURE

Oesophagectomy

Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

DRUG

Neoadjuvant chemotherapy

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Herui Yao, PhD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Haiyu Zhou, PhD · Guangdong Provincial People's Hospital

  • Michael Lanuti, PhD · Massachusetts General Hospital of Harvard Medical School

Eligibility

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

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2019-12-01
Completion
2019-12-01
FDA Drug
Yes

Countries

  • United States
  • 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 NCT04027543 on ClinicalTrials.gov